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.
Wednesday, January 30, 2008
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.