Question:
How is galvanic corrosion prevented when cleaning aluminum?
Answer:
Aluminum is an active metal that is somewhat high on the "anodic index" of the galvanic series. If aluminum is cleaned with other metals present, you can create a battery and get galvanic corrosion. Aluminum should not be cleaned in the presence of metals that are significantly higher or lower on the anodic series; higher on the anodic scale such as zinc, magnesium or beryllium metals and lower on the anodic scale such as tin, brass, bronze, copper, silver, nickel and rhodium. Galvanic corrosion is facilitated between aluminum and other metals that may be dissolved in the cleaning bath from prior cleaning, or present in the cleaning bath during the time of cleaning. The corrosion can take the form of a dark grey film or deposit, a brown film or deposit, and with more exotic metals, other colors are possible. Certain cast alloys of aluminum can have galvanic corrosion problems with cast iron, carbon steel and low alloy steels. Note that intact and properly passivated stainless steel does not have a problem with galvanic corrosion on aluminum during normal cleaning.
The Alconox brand cleaners recommended for cleaning aluminum are Alconox, Liquinox, Tergazyme, Alcojet, Alcotabs, Detojet, Citranox, Luminox, Citrajet, Solujet and Tergajet. Detergent 8 is not recommended for cleaning aluminum. Aluminum that has been exposed to the environment often forms a characteristic dull grey surface oxide. None of the recommended cleaners will remove this and brighten the aluminum again. The recommended cleaners are intended for use in removing residues, not surface oxides that are bound in to the aluminum matrix. To clean this type of aluminum, there are very hazardous strong acid cleaners that can sometimes be effective. Alternatively, there are mild abrasive cleaners that can be used to polish the dark coating off the aluminum surface. Alconox does not make any of these kinds of cleaners.
Friday, February 01, 2008
Wednesday, January 30, 2008
Aluminum Compatibility with Alconox Cleaners
Question:
Which Alconox cleaners can be used on Aluminum?
Answer:
The Alconox brand cleaners recommended for cleaning aluminum are Alconox, Liquinox, Tergazyme, Alcojet, Alcotabs, Detojet, Citranox, Luminox, Citrajet, Solujet and Tergajet. Detergent 8 is not recommended for cleaning aluminum.
Aluminum forms a natural passive layer in air that allows it to be successfully cleaned without adverse reactions with cleaner. A passive layer forms in under an hour, provided there is no oily film present. Once the passive layer is formed, the recommended Alconox brand cleaners can be used to clean the aluminum at concentrations of less than 5% at 90 deg C or less for up to one hour. All the recommended high pH cleaners: Alcojet, Detojet, Solujet and Tergajet contain silicate corrosion inhibitors to protect the aluminum during high pH cleaning. Cleaning aluminum with a high pH cleaner above about pH 10 without a corrosion inhibitor would result in dark aluminum oxide corrosion. The protection conferred by the silicate corrosion inhibitor is a blocking of any active sites on the aluminum. These Alumino-silicates do not leave a filmy residue on the surface, whereas other types of corrosion inhibitors such as filming amines do leave behind a filmy residue. These spot alumino-silicates do not particularly change the appearance, electrical, mechanical or bonding properties of the aluminum. In the case where the aluminum did not form a passive layer, the aluminum can be attacked by cleaners. If that is the case, then it would be safest to use an acid cleaner such as Citranox or Citrajet; or a light duty neutral cleaner such as Luminox to clean the aluminum.
Which Alconox cleaners can be used on Aluminum?
Answer:
The Alconox brand cleaners recommended for cleaning aluminum are Alconox, Liquinox, Tergazyme, Alcojet, Alcotabs, Detojet, Citranox, Luminox, Citrajet, Solujet and Tergajet. Detergent 8 is not recommended for cleaning aluminum.
Aluminum forms a natural passive layer in air that allows it to be successfully cleaned without adverse reactions with cleaner. A passive layer forms in under an hour, provided there is no oily film present. Once the passive layer is formed, the recommended Alconox brand cleaners can be used to clean the aluminum at concentrations of less than 5% at 90 deg C or less for up to one hour. All the recommended high pH cleaners: Alcojet, Detojet, Solujet and Tergajet contain silicate corrosion inhibitors to protect the aluminum during high pH cleaning. Cleaning aluminum with a high pH cleaner above about pH 10 without a corrosion inhibitor would result in dark aluminum oxide corrosion. The protection conferred by the silicate corrosion inhibitor is a blocking of any active sites on the aluminum. These Alumino-silicates do not leave a filmy residue on the surface, whereas other types of corrosion inhibitors such as filming amines do leave behind a filmy residue. These spot alumino-silicates do not particularly change the appearance, electrical, mechanical or bonding properties of the aluminum. In the case where the aluminum did not form a passive layer, the aluminum can be attacked by cleaners. If that is the case, then it would be safest to use an acid cleaner such as Citranox or Citrajet; or a light duty neutral cleaner such as Luminox to clean the aluminum.
Thursday, January 24, 2008
Pharma TOC Residue Detection Method
Question:
What is TOC and is TOC an acceptable residue detection method for Alconox Brand Aqueous Cleaners?
Answer:
Total organic carbon (TOC) is the amount of carbon bound in an organic compound and is often used as a non-specific indicator of water quality or cleanliness of pharmaceutical manufacturing equipment. A typical analysis for TOC measures both the total carbon present as well as the inorganic carbon. Subtracting the inorganic carbon from the total carbon yields TOC. The United States Pharmacopoeia recognizes TOC as a required test for purified water and water for injection. For this reason, TOC has found acceptance as a process control attribute in the biotechnology industry to monitor the performance of unit operations comprising purification and distribution systems. As many of these biotechnology operations include the preparation of medicines, FDA enacts numerous regulations to protect the health of the public and ensure the product quality is maintained. To make sure there is no cross contamination between product runs of different drugs various cleaning procedures are performed. TOC concentration levels are used to track the success of these cleaning validation procedures especially clean-in-place (CIP).
TOC analysis has been reported to detect the organic surfactants present in ALCONOX (11% w/w), LIQUI-NOX (21% w/w), TERG-A-ZYME (11% w/w), ALCOJET (1.5% w/w), ALCOTABS (20% w/w), DETERGENT 8 (38% w/w), LUMINOX (26% w/w) CITRANOX (17% w/w), CITRAJET (14% w/w), TERGAJET (10.5% w/w) and SOLUJET (6% w/w). You must go through the acid neutralization step or use the inorganic carbon channel on the TOC analyzer to account for inorganic carbon.
For more information, Ask the Alconox Critical Cleaning Experts! Visit here to ask a questions.
What is TOC and is TOC an acceptable residue detection method for Alconox Brand Aqueous Cleaners?
Answer:
Total organic carbon (TOC) is the amount of carbon bound in an organic compound and is often used as a non-specific indicator of water quality or cleanliness of pharmaceutical manufacturing equipment. A typical analysis for TOC measures both the total carbon present as well as the inorganic carbon. Subtracting the inorganic carbon from the total carbon yields TOC. The United States Pharmacopoeia recognizes TOC as a required test for purified water and water for injection. For this reason, TOC has found acceptance as a process control attribute in the biotechnology industry to monitor the performance of unit operations comprising purification and distribution systems. As many of these biotechnology operations include the preparation of medicines, FDA enacts numerous regulations to protect the health of the public and ensure the product quality is maintained. To make sure there is no cross contamination between product runs of different drugs various cleaning procedures are performed. TOC concentration levels are used to track the success of these cleaning validation procedures especially clean-in-place (CIP).
TOC analysis has been reported to detect the organic surfactants present in ALCONOX (11% w/w), LIQUI-NOX (21% w/w), TERG-A-ZYME (11% w/w), ALCOJET (1.5% w/w), ALCOTABS (20% w/w), DETERGENT 8 (38% w/w), LUMINOX (26% w/w) CITRANOX (17% w/w), CITRAJET (14% w/w), TERGAJET (10.5% w/w) and SOLUJET (6% w/w). You must go through the acid neutralization step or use the inorganic carbon channel on the TOC analyzer to account for inorganic carbon.
For more information, Ask the Alconox Critical Cleaning Experts! Visit here to ask a questions.
Tuesday, January 22, 2008
Validation Support
Question:
Does Alconox provide cleaning validation tech support?
Answer:
Alconox, Inc Technical Support welcomes the opportunity to assist our customers in validating Alconox brand cleaners. In fact, Alconox Technical Support has written Cleaning Validation References specifically to help with residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and writing a procedure and training operators. A downloadable version of the Cleaning Validation References is available here.
Cleaning validation literature can also be requested through postal mail by visiting here.
Also, if you have a specific question concerning cleaning validation "Ask Alconox" by visiting here.
To speak with a cleaning validation expert directly, call 914-948-4040 extension 160 for Malcolm McLaughlin or email at mmclaughlin@alconox.com
Does Alconox provide cleaning validation tech support?
Answer:
Alconox, Inc Technical Support welcomes the opportunity to assist our customers in validating Alconox brand cleaners. In fact, Alconox Technical Support has written Cleaning Validation References specifically to help with residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and writing a procedure and training operators. A downloadable version of the Cleaning Validation References is available here.
Cleaning validation literature can also be requested through postal mail by visiting here.
Also, if you have a specific question concerning cleaning validation "Ask Alconox" by visiting here.
To speak with a cleaning validation expert directly, call 914-948-4040 extension 160 for Malcolm McLaughlin or email at mmclaughlin@alconox.com
Tuesday, January 15, 2008
Pharma Critical Cleaning and 21 CFR 211.67
Question:
Why is critical cleaning necessary for the pharmaceutical industry? Are Alconox brand cleaners formulated to be used in the pharmaceutical industry?
Answer:
All pharmaceutical products, prescription and over-the-counter, available for use in the U.S. must be produced according to the FDA's cGMP regulations. These guidelines are in accordance with Finished Pharmaceuticals (human and animal products): Title 21 CFR 210 and 21 CFR 211.
§ 211.67 Equipment cleaning and maintenance.
a) Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
(b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following:
(1) Assignment of responsibility for cleaning and maintaining equipment;
(2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;
(3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance;
(4) Removal or obliteration of previous batch identification;
(5) Protection of clean equipment from contamination prior to use;
(6) Inspection of equipment for cleanliness immediately before use.
(c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in §211.180 and §211.182.
Alconox offers a range of pharmaceutical grade critical cleaners.
Alconox brand cleaners are widely used in the pharmaceutical industry because they easy to validate, leave no interfering residues on hard surfaces, are biodegradable and readily disposable. Moreover, a multi-product pharmaceutical manufacturing plant with multi-cleaning needs can often find a single Alconox brand aqueous cleaner for all needs, resulting in reduced cost. All Alconox brands are GMP compliant and have downloadable lot specific Certificate of Analysis (COA), MSDS, Technical Bulletins, Trace Analysis. Alconox Critical Cleaning Experts have written Pharmaceutical Cleaning Validation References that includes a Directory of Cleaner Residue Detection Methods for each Alconox Detergent. To download your free copy please visit here.
Why is critical cleaning necessary for the pharmaceutical industry? Are Alconox brand cleaners formulated to be used in the pharmaceutical industry?
Answer:
All pharmaceutical products, prescription and over-the-counter, available for use in the U.S. must be produced according to the FDA's cGMP regulations. These guidelines are in accordance with Finished Pharmaceuticals (human and animal products): Title 21 CFR 210 and 21 CFR 211.
§ 211.67 Equipment cleaning and maintenance.
a) Equipment and utensils shall be cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
(b) Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product. These procedures shall include, but are not necessarily limited to, the following:
(1) Assignment of responsibility for cleaning and maintaining equipment;
(2) Maintenance and cleaning schedules, including, where appropriate, sanitizing schedules;
(3) A description in sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operations, and the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance;
(4) Removal or obliteration of previous batch identification;
(5) Protection of clean equipment from contamination prior to use;
(6) Inspection of equipment for cleanliness immediately before use.
(c) Records shall be kept of maintenance, cleaning, sanitizing, and inspection as specified in §211.180 and §211.182.
Alconox offers a range of pharmaceutical grade critical cleaners.
Alconox brand cleaners are widely used in the pharmaceutical industry because they easy to validate, leave no interfering residues on hard surfaces, are biodegradable and readily disposable. Moreover, a multi-product pharmaceutical manufacturing plant with multi-cleaning needs can often find a single Alconox brand aqueous cleaner for all needs, resulting in reduced cost. All Alconox brands are GMP compliant and have downloadable lot specific Certificate of Analysis (COA), MSDS, Technical Bulletins, Trace Analysis. Alconox Critical Cleaning Experts have written Pharmaceutical Cleaning Validation References that includes a Directory of Cleaner Residue Detection Methods for each Alconox Detergent. To download your free copy please visit here.
Thursday, January 10, 2008
Medical Device Cleaning
Question:
What classes of medical devices are Alconox brand cleaners formulated to clean?
Answer:
Alconox brand cleaners are formulated to clean Class I, II, and III medical devices. For further information please visit the Alconox website at http://www.alconox.com/static/section_customer/ind_meddev.asp.
According to www.fda.gov, the FDA classifies medical devices into three categories. Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user. Class II are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. Special controls may include special labeling requirements, mandatory performance standards and post market surveillance. Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
What classes of medical devices are Alconox brand cleaners formulated to clean?
Answer:
Alconox brand cleaners are formulated to clean Class I, II, and III medical devices. For further information please visit the Alconox website at http://www.alconox.com/static/section_customer/ind_meddev.asp.
According to www.fda.gov, the FDA classifies medical devices into three categories. Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user. Class II are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. Special controls may include special labeling requirements, mandatory performance standards and post market surveillance. Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls. Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
Tuesday, January 08, 2008
ISO Certification
Question:
What is ISO 9000? Can Alconox brand cleaners be used by companies with ISO 9000 certification?
Answer:
ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies.
Alconox brand cleaners are GMP compliant and are often used by companies with ISO 9000 certification.
What is ISO 9000? Can Alconox brand cleaners be used by companies with ISO 9000 certification?
Answer:
ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies.
Alconox brand cleaners are GMP compliant and are often used by companies with ISO 9000 certification.
Thursday, December 20, 2007
GHTF
Question:
What is the GHTF?
Answer:
Directly taken from www.GHTF.org, The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework. The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness, performance and quality of medical devices, as well as promoting technological innovation and facilitating international trade. The primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices.
In this regard, Alconox aqueous cleaners are formulated to scrupulously clean medical devices to help manufacturer meet specified regulations, for more information please visit http://www.alconox.com/static/section_customer/ind_meddev.asp.
What is the GHTF?
Answer:
Directly taken from www.GHTF.org, The Global Harmonization Task Force (GHTF) is a voluntary group of representatives from national medical device regulatory authorities and the regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework. The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness, performance and quality of medical devices, as well as promoting technological innovation and facilitating international trade. The primary way in which this is accomplished is via the publication and dissemination of harmonized guidance documents on basic regulatory practices.
In this regard, Alconox aqueous cleaners are formulated to scrupulously clean medical devices to help manufacturer meet specified regulations, for more information please visit http://www.alconox.com/static/section_customer/ind_meddev.asp.
Tuesday, December 18, 2007
ICH
Question:
What is the objective of the ICH?
Answer:
According to www.ICH.org, The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The objective of ICH is to increase international harmonisation of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner. These activities have been undertaken to promote public health, prevent unnecessary duplication of clinical trials in humans, and minimize the use of animal testing without compromising safety and effectiveness.
In this regard, keeping manufacturing equipment clean is necessary to avoid cross contamination. To ensure safety requirements are met and to maintain a high standard of quality for products, many pharmaceutical manufacturers use Alconox brand products for critical cleaning. Learn more about Alconox aqueous cleaners and validation support offered by Alconox critical cleaning experts! Visit www.alconox.com for more information.
What is the objective of the ICH?
Answer:
According to www.ICH.org, The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The objective of ICH is to increase international harmonisation of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost-effective manner. These activities have been undertaken to promote public health, prevent unnecessary duplication of clinical trials in humans, and minimize the use of animal testing without compromising safety and effectiveness.
In this regard, keeping manufacturing equipment clean is necessary to avoid cross contamination. To ensure safety requirements are met and to maintain a high standard of quality for products, many pharmaceutical manufacturers use Alconox brand products for critical cleaning. Learn more about Alconox aqueous cleaners and validation support offered by Alconox critical cleaning experts! Visit www.alconox.com for more information.
Thursday, December 13, 2007
Cleaning Validation Information
Question:
What is a definition of cleaning validation? Does Alconox provide cleaning validation support for Alconox brand cleaners?
Answer:
Cleaning Validation - Documented evidence with a high degree of certainty that a cleaning process will consistently produce product meeting its predetermined quality attributes. Quality attributes are typically those related to potentially contaminating residues.
Alconox, Inc provides validation support on all Alconox brand cleaners to assist in meeting cGMP guidelines. In fact, Alconox, Inc technical team has written The Aqueous Cleaning Handbook, and has dedicated chapters to Cleaning Validation (Chapter 8) and to Measuring Cleanliness (Chapter 10). For more information or get your free copy of The Aqueous Cleaning Handbook visit, http://www.alconox.com/section_customer/book_info.asp.
What is a definition of cleaning validation? Does Alconox provide cleaning validation support for Alconox brand cleaners?
Answer:
Cleaning Validation - Documented evidence with a high degree of certainty that a cleaning process will consistently produce product meeting its predetermined quality attributes. Quality attributes are typically those related to potentially contaminating residues.
Alconox, Inc provides validation support on all Alconox brand cleaners to assist in meeting cGMP guidelines. In fact, Alconox, Inc technical team has written The Aqueous Cleaning Handbook, and has dedicated chapters to Cleaning Validation (Chapter 8) and to Measuring Cleanliness (Chapter 10). For more information or get your free copy of The Aqueous Cleaning Handbook visit, http://www.alconox.com/section_customer/book_info.asp.
Tuesday, December 11, 2007
Calculating Cleaning Agent Safety Based Limits
Question:
Does Alconox provide information on calculating cleaning agent safety based limits?
Answer:
Alconox, Inc Pharmaceutical Cleaning Validation Method References has an entire section dedicated to cleaning agent safety based limits. Please visit here for more information: http://www.alconox.com/static/section_top/gen_cleanval.asp.
Cleaning agent safety based limits are typically calculated from a safety factor of an acceptable daily intake (ADI), a (1/1000 or more) reduction of an LD50 preferably by the same route of administration, or reproductive hazard levels. If the calculated limit is found to be higher than a less than 10 ppm carryover to the next batch, then the limit can be set to the more stringent 10 ppm carryover level for the safety based limit.
For additional information, the Alconox Technical Team has also written The Aqueous Cleaning Handbook, which in Chapter 10 discusses Measuring Cleanliness. For more information on the Handbook visit http://www.alconox.com/section_customer/book_info.asp.
Does Alconox provide information on calculating cleaning agent safety based limits?
Answer:
Alconox, Inc Pharmaceutical Cleaning Validation Method References has an entire section dedicated to cleaning agent safety based limits. Please visit here for more information: http://www.alconox.com/static/section_top/gen_cleanval.asp.
Cleaning agent safety based limits are typically calculated from a safety factor of an acceptable daily intake (ADI), a (1/1000 or more) reduction of an LD50 preferably by the same route of administration, or reproductive hazard levels. If the calculated limit is found to be higher than a less than 10 ppm carryover to the next batch, then the limit can be set to the more stringent 10 ppm carryover level for the safety based limit.
For additional information, the Alconox Technical Team has also written The Aqueous Cleaning Handbook, which in Chapter 10 discusses Measuring Cleanliness. For more information on the Handbook visit http://www.alconox.com/section_customer/book_info.asp.
Thursday, December 06, 2007
Electronics Cleaning with no Hazardous Chemicals or Volatile Solvents
Question:
Why is it beneficial to use Detergent 8 when cleaning circuit boards and electronic components?
Answer:
Detergent 8 contains no conductive metal cations, and therefore it cannot leave conductive residues. Its coupling ability keeps soils suspended in the cleaning solution, not on the circuit boards. If the solution is promptly washed away with deionized water, boards will meet the omega-meter or ionograph standards of cleanliness. Detergent 8 can be used in a variety of electronic applications, such as, cleaning glass substrate before dichloric coating of electronic parts, cleaning during manufacturing and assembly, cleaning electronic contacts and leads as well as ceramic insulators and components.
Detergent 8 can be used manually, soak or spray. For more information please visit http://www.alconox.com/downloads/pdf/techbull_detergent8.pdf.
For more on cleaning electronics, please visit Alconox website at http://www.alconox.com/static/section_customer/ind_electronics.asp.
Why is it beneficial to use Detergent 8 when cleaning circuit boards and electronic components?
Answer:
Detergent 8 contains no conductive metal cations, and therefore it cannot leave conductive residues. Its coupling ability keeps soils suspended in the cleaning solution, not on the circuit boards. If the solution is promptly washed away with deionized water, boards will meet the omega-meter or ionograph standards of cleanliness. Detergent 8 can be used in a variety of electronic applications, such as, cleaning glass substrate before dichloric coating of electronic parts, cleaning during manufacturing and assembly, cleaning electronic contacts and leads as well as ceramic insulators and components.
Detergent 8 can be used manually, soak or spray. For more information please visit http://www.alconox.com/downloads/pdf/techbull_detergent8.pdf.
For more on cleaning electronics, please visit Alconox website at http://www.alconox.com/static/section_customer/ind_electronics.asp.
Tuesday, December 04, 2007
ar Reactor Cavity and Equipment Decontamination
Question:
What cleaner does Alconox recommend for the decontamination of nuclear reactor cavities and related equipment?
Answer:
Alconox recommends Detergent 8, a non-ionic, phosphate-free homogeneous blend of an alkanolamine, glycol ethers and an alkoxylated fatty alcohol for decontaminating nuclear reactors and related equipment including pipes, tools, and protective equipment. It contains no chelating agents or halides, or conductive metal cations. It is imperative to avoid detergents containing chelating agents as they can bond chemically to radioisotopes. Also it is important to avoid detergents containing fluorides, chlorides, or sulfur ingredients which might cause surface corrosion or intergranular stress corrosion of stainless components.
If the key concern is avoiding waste interference, then Detergent 8 is the brand to use. Detergent 8 can be used manually, soak or spray. For more information please click here.
Use Alconox brand products in the nuclear industry! Visit our website.
What cleaner does Alconox recommend for the decontamination of nuclear reactor cavities and related equipment?
Answer:
Alconox recommends Detergent 8, a non-ionic, phosphate-free homogeneous blend of an alkanolamine, glycol ethers and an alkoxylated fatty alcohol for decontaminating nuclear reactors and related equipment including pipes, tools, and protective equipment. It contains no chelating agents or halides, or conductive metal cations. It is imperative to avoid detergents containing chelating agents as they can bond chemically to radioisotopes. Also it is important to avoid detergents containing fluorides, chlorides, or sulfur ingredients which might cause surface corrosion or intergranular stress corrosion of stainless components.
If the key concern is avoiding waste interference, then Detergent 8 is the brand to use. Detergent 8 can be used manually, soak or spray. For more information please click here.
Use Alconox brand products in the nuclear industry! Visit our website.
Tuesday, November 27, 2007
Alconox Brands for Ultrasonic Tank Cleaning
Question:
What is ultrasonic tank cleaning? Which industries commonly employ the method? What Alconox, Inc brands would be ideal for ultrasonic tank cleaning?
Answer:
Ultrasonic Tank cleaning works best on objects or part that are made of stainless steel, mild steel, aluminum, copper, brass, other alloys, plastic or rubber. The object to be cleaned is placed in a chamber containing a suitable ultrasound conducting fluid such as an aqueous cleaner depending on the application. Aqueous cleaners typically contain surfactants that reduce the surface tension of the water. An ultrasound generating transducer is built into the chamber, or may be lowered into the fluid. It is electronically activated to produce ultrasonic waves in the fluid. The main mechanism of cleaning action is by energy released from the creation and collapse of microscopic cavitation bubbles, which break up and lift off dirt and contaminants from the surface to be cleaned. The higher the frequency, the smaller the nodes between the cavitation points which allows for more precise cleaning.
Industrial ultrasonic cleaners are used in the automotive, printing, marine, medical instruments, medical device manufacturing, electroplating, and weapons industries.
Liquinox, critical cleaning liquid detergent, is a high emulsifying cleaner that is an excellent product for use in soak and ultrasonic cleaning. Citranox, acid cleaner and detergent, is also a high-emulsifying cleaner ideal for metal oxides and deposits.
Technical Bulletins and MSDS for each are downloadable from www.alconox.com or
What is ultrasonic tank cleaning? Which industries commonly employ the method? What Alconox, Inc brands would be ideal for ultrasonic tank cleaning?
Answer:
Ultrasonic Tank cleaning works best on objects or part that are made of stainless steel, mild steel, aluminum, copper, brass, other alloys, plastic or rubber. The object to be cleaned is placed in a chamber containing a suitable ultrasound conducting fluid such as an aqueous cleaner depending on the application. Aqueous cleaners typically contain surfactants that reduce the surface tension of the water. An ultrasound generating transducer is built into the chamber, or may be lowered into the fluid. It is electronically activated to produce ultrasonic waves in the fluid. The main mechanism of cleaning action is by energy released from the creation and collapse of microscopic cavitation bubbles, which break up and lift off dirt and contaminants from the surface to be cleaned. The higher the frequency, the smaller the nodes between the cavitation points which allows for more precise cleaning.
Industrial ultrasonic cleaners are used in the automotive, printing, marine, medical instruments, medical device manufacturing, electroplating, and weapons industries.
Liquinox, critical cleaning liquid detergent, is a high emulsifying cleaner that is an excellent product for use in soak and ultrasonic cleaning. Citranox, acid cleaner and detergent, is also a high-emulsifying cleaner ideal for metal oxides and deposits.
Technical Bulletins and MSDS for each are downloadable from www.alconox.com or
- Liquinox Tech Bulletin: http://www.alconox.com/downloads/pdf/techbull_liquinox.pdf
- Liquinox MSDS: http://www.alconox.com/static/msds/msds_liquinox.asp
- Citranox Tech Bulletin: http://www.alconox.com/downloads/pdf/techbull_citranox.pdf
- Citranox MSDS: http://www.alconox.com/static/msds/msds_citranox.asp
Tuesday, November 20, 2007
Alconox Brands for Clean-In-Place (CIP) Systems
Question:
What Alconox brand cleaners are recommended for Clean-In-Place (CIP) systems? What information does Alconox offer to assist in validating CIP cleaners?
Answer:
What Alconox brand cleaners are recommended for Clean-In-Place (CIP) systems? What information does Alconox offer to assist in validating CIP cleaners?
Answer:
It is desirable to use a low foaming cleaner that rinses freely in a CIP system. Selecting the appropriate CIP cleaner will be determined by the type of soil being removed as well as the hard surface being cleaned. Alconox, Inc manufacturers' several low foaming liquid cleaners that work well in CIP, including Solujet, an alkaline cleaner, and Citrajet, an acidic cleaner. An alkaline cleaner best removes oils, fats, grease and an acidic cleaner works best to remove insoluble hydroxides and metal oxides. Both Solujet and Citrajet are suitable to use on stainless steel manufacturing surfaces.
- Technical Bulletins and MSDS for each are downloadable from www.alconox.com
- Solujet Technical Bulletin: http://www.alconox.com/downloads/pdf/techbull_solujet.pdf
- Solujet MSDS: http://www.alconox.com/static/msds/msds_solujet.asp
- Citrajet Technical Bulletin: http://www.alconox.com/downloads/pdf/techbull_citrajet.pdf
- Citrajet MSDS: http://www.alconox.com/static/msds/msds_citrajet.asp
Alconox, Inc provides assistance to validate cleaners for CIP systems. Information on residue detection methods for Solujet and Citrajet can be found at http://www.alconox.com/static/section_top/gen_cleanval.asp.
Thursday, November 15, 2007
Pharma Clean In Place (CIP) and Standard Operating Procedures (SOPs)
Question:
What is clean in place (CIP)? What are four reasons the pharmaceutical industry commonly employs clean in place (CIP) systems? Does Alconox, Inc have information on CIP Standard Operation Procedures (SOPs)?
Answer:
CIP stands for Clean-In-Place and is a method of cleaning the interior surfaces of closed systems and process equipment without dismantling the equipment. There are different types of CIP including, single pass systems and recirculation system.
The pharmaceutical industry heavily relies on clean in place (CIP) system because operators are not required to enter plant to clean, difficult to access areas can be cleaned, production time between production runs is minimized, and recycling the cleaner can reduce cost. Equipment used in pharmaceutical manufacturing must be cleaned before each use, and the cleaning procedure used must be in accordance with good manufacturing practices (GMPs). Alconox provides support to meet cGMP regulations. In fact, Alconox, Inc technical team has written The Aqueous Cleaning Handbook, where Standard Operating Procedures for CIP systems are discussed (see Chapter 7). For more information or get your free copy of The Aqueous Cleaning Handbook visit, http://www.alconox.com/section_customer/book_info.asp.
What is clean in place (CIP)? What are four reasons the pharmaceutical industry commonly employs clean in place (CIP) systems? Does Alconox, Inc have information on CIP Standard Operation Procedures (SOPs)?
Answer:
CIP stands for Clean-In-Place and is a method of cleaning the interior surfaces of closed systems and process equipment without dismantling the equipment. There are different types of CIP including, single pass systems and recirculation system.
The pharmaceutical industry heavily relies on clean in place (CIP) system because operators are not required to enter plant to clean, difficult to access areas can be cleaned, production time between production runs is minimized, and recycling the cleaner can reduce cost. Equipment used in pharmaceutical manufacturing must be cleaned before each use, and the cleaning procedure used must be in accordance with good manufacturing practices (GMPs). Alconox provides support to meet cGMP regulations. In fact, Alconox, Inc technical team has written The Aqueous Cleaning Handbook, where Standard Operating Procedures for CIP systems are discussed (see Chapter 7). For more information or get your free copy of The Aqueous Cleaning Handbook visit, http://www.alconox.com/section_customer/book_info.asp.
Tuesday, November 13, 2007
Alconox, Inc Provides Pharma Cleaning Validation Support
Question:
What is pharmaceutical cleaning validation? What information can Alconox, Inc provide to support pharmaceutical cleaning validation?
Answer:
Cleaning validation is the methodology used to assure that a cleaning process removes any residues of the active pharmaceutical ingredients (API) of the product manufactured, as well as any residual cleaning agent utilized in the cleaning process and any microbial contaminants on the surface of the manufacturing equipment or utensil. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product.
Alconox, Inc provides validation support to help meet pharmaceutical cGMP requirements. Alconox, Inc Technical Team has written Pharmaceutical Cleaning Validation References that includes a directory of cleaner residue detection methods for each Alconox brand. Also to help comply with cGMP regulations all cleaner brands have traceable lot specific certificate of analysis (COA), Technical Bulletins and MSDS.
What is pharmaceutical cleaning validation? What information can Alconox, Inc provide to support pharmaceutical cleaning validation?
Answer:
Cleaning validation is the methodology used to assure that a cleaning process removes any residues of the active pharmaceutical ingredients (API) of the product manufactured, as well as any residual cleaning agent utilized in the cleaning process and any microbial contaminants on the surface of the manufacturing equipment or utensil. All residues are removed to predetermined levels to ensure the quality of the next product manufactured is not compromised by waste from the previous product.
Alconox, Inc provides validation support to help meet pharmaceutical cGMP requirements. Alconox, Inc Technical Team has written Pharmaceutical Cleaning Validation References that includes a directory of cleaner residue detection methods for each Alconox brand. Also to help comply with cGMP regulations all cleaner brands have traceable lot specific certificate of analysis (COA), Technical Bulletins and MSDS.
Thursday, November 08, 2007
Alconox, Inc Support Pharma Manufacturers with CFR-Part 211.67
Question:
What is 21 CFR-Part 211.67? How can Alconox, Inc help pharmaceutical manufacturers meet these requirements?
Answer:
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published by the Government Printing Office (GPO) in the Federal Register (FR) by the Executive departments and agencies of the Federal Government. The FDA regulatory guidelines specifically for Title 21 CFR-Part 211.67 details the FDA clean standards on Equipment Cleaning and Maintenance. For more details visit, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67.
The Alconox technical support team has developed a guide for cleaning validation to help the pharmaceutical manufacturer meet these standards. The cleaning validation involves residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and finally writing a procedure and training operators. This procedure is used to document acceptable residues three or more times and then establish a rational monitoring program that verifies that the validated state is being maintained. For more information please visit the Alconox website at www.alconox.com/static/section_top/gen_cleanval.asp.
What is 21 CFR-Part 211.67? How can Alconox, Inc help pharmaceutical manufacturers meet these requirements?
Answer:
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published by the Government Printing Office (GPO) in the Federal Register (FR) by the Executive departments and agencies of the Federal Government. The FDA regulatory guidelines specifically for Title 21 CFR-Part 211.67 details the FDA clean standards on Equipment Cleaning and Maintenance. For more details visit, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=211.67.
The Alconox technical support team has developed a guide for cleaning validation to help the pharmaceutical manufacturer meet these standards. The cleaning validation involves residue identification, residue detection method selection, sampling method selection, setting residue acceptance criteria, methods validation and recovery studies, and finally writing a procedure and training operators. This procedure is used to document acceptable residues three or more times and then establish a rational monitoring program that verifies that the validated state is being maintained. For more information please visit the Alconox website at www.alconox.com/static/section_top/gen_cleanval.asp.
Tuesday, November 06, 2007
MD&M East 2008, Alconox Booth #2266
Question:
Will Alconox, Inc attend the MD&M East Show in 2008?
Answer:
Alconox, Inc will be attending the MD&M East Show at the Jacob Javits Center New York City, NY on June 3-5. Stop by our booth #2266 for your free copy the Guide to Critical Cleaning or Aqueous Cleaning Handbook!
You'll want to visit Alconox, Inc booth #2266 at MD&M EAST because...
Alconox, Inc is The Leader in Critical Cleaning Detergents with sixty years of experience getting medical equipment critically clean for use in demanding human or veterinary health applications, and in the manufacturing of medical devices - such as titanium prosthetic hip joints - we understand how to clean to implantable standards. Whether the product is designed for in vitro or in vivo use, is biomechanical or electronic, you'll find an Alconox cleaner expressly formulated to get products scrupulously clean without leaving interfering residues.
You'll meet the Alconox, Inc technical experts who are ready to discuss your cleaning validation needs!
MD&M is the recognized resource since 1983 for everything you need to design and manufacture medical devices and equipment for today's increasingly competitive healthcare marketplace. For more information please visit this website: http://www.devicelink.com/expo/east07/.
Will Alconox, Inc attend the MD&M East Show in 2008?
Answer:
Alconox, Inc will be attending the MD&M East Show at the Jacob Javits Center New York City, NY on June 3-5. Stop by our booth #2266 for your free copy the Guide to Critical Cleaning or Aqueous Cleaning Handbook!
You'll want to visit Alconox, Inc booth #2266 at MD&M EAST because...
Alconox, Inc is The Leader in Critical Cleaning Detergents with sixty years of experience getting medical equipment critically clean for use in demanding human or veterinary health applications, and in the manufacturing of medical devices - such as titanium prosthetic hip joints - we understand how to clean to implantable standards. Whether the product is designed for in vitro or in vivo use, is biomechanical or electronic, you'll find an Alconox cleaner expressly formulated to get products scrupulously clean without leaving interfering residues.
You'll meet the Alconox, Inc technical experts who are ready to discuss your cleaning validation needs!
MD&M is the recognized resource since 1983 for everything you need to design and manufacture medical devices and equipment for today's increasingly competitive healthcare marketplace. For more information please visit this website: http://www.devicelink.com/expo/east07/.
Thursday, November 01, 2007
Interphex2008, Alconox Booth #107
Question:
Will Alconox, Inc attend the INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition?
Answer:
Alconox, Inc will be attending the INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition at the Pennsylvania Convention Center - Philadelphia, PA March 26-28, 2008. Stop by our booth #107 for your free copy the Guide to Critical Cleaning or Aqueous Cleaning Handbook! Great opportunity to "Ask Alconox" and get experts advice about your industrial cleaning needs! Mark your calendars for INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition!
INTERPHEX is the world's most trusted source for leading-edge technology, education, and sourcing of the products and services that drive scientific innovation for Life Sciences manufacturing from drug development to market - accelerating regulated products for patient care globally.
INTERPHEX is the only Life Sciences event that represents a true cross-section of the pharmaceutical and biopharmaceutical industries. Industry-leading professionals worldwide make INTERPHEX the industry's annual focal point for driving change and efficiencies for the global pharmaceutical and biopharmaceutical market.
INTERPHEX will once again feature the co-location of PharmaMedDevice, the only comprehensive event to focus on the convergence of medical device, pharmaceutical, and biologic industries.
For more information about INTERPHEX, please click here.
Will Alconox, Inc attend the INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition?
Answer:
Alconox, Inc will be attending the INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition at the Pennsylvania Convention Center - Philadelphia, PA March 26-28, 2008. Stop by our booth #107 for your free copy the Guide to Critical Cleaning or Aqueous Cleaning Handbook! Great opportunity to "Ask Alconox" and get experts advice about your industrial cleaning needs! Mark your calendars for INTERPHEX2008 Pharmaceutical Manufacturing Conference and Exhibition!
INTERPHEX is the world's most trusted source for leading-edge technology, education, and sourcing of the products and services that drive scientific innovation for Life Sciences manufacturing from drug development to market - accelerating regulated products for patient care globally.
INTERPHEX is the only Life Sciences event that represents a true cross-section of the pharmaceutical and biopharmaceutical industries. Industry-leading professionals worldwide make INTERPHEX the industry's annual focal point for driving change and efficiencies for the global pharmaceutical and biopharmaceutical market.
INTERPHEX will once again feature the co-location of PharmaMedDevice, the only comprehensive event to focus on the convergence of medical device, pharmaceutical, and biologic industries.
For more information about INTERPHEX, please click here.
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