Question:
What med dev information is in the Medical Device Cleaning Validation References?
Answer:
The Medical Device Cleaning Validation References for Alconox Detergents contains information about identifying residues, selecting a residue detection method, selecting a sampling method, setting residue acceptance criteria, and more. Also included is a directory of cleaner residue detection methods for each Alconox detergent. Also available is the Alconox team of experts who provide validation support. To get a copy of the Alconox Medical Device Cleaning Validation References or to speak with a cleaning validation expert email cleaning@alconox.com or call 914-948-4040.
Tuesday, September 30, 2008
Thursday, September 25, 2008
MedDev Cleaning Validation Consultant
Question:
Does Alconox, Inc. offer validation consultants to provide validation tech support?
Answer:
Yes, Alconox can provide valuable consulting and information to medical device manufacturers. Our critical cleaning experts can discuss validation concerns such as techniques for determining acceptable residual levels and analytical methods for residue quantitation.
Alconox, Inc. supplies detergents to medical device manufacturing companies that require exacting levels of quality control and technical service. Alconox, Inc. provides support for regulatory-compliant cleaning validations which includes lot number traceability of all cleaners and ingredients, cleaner toxicity and reactivity/degradation information, shelf-life testing, residue sampling, detection methods and written cleaning procedures.
Discuss worst case critical cleaning issues with the experts. 'Ask Alconox' at cleaning@alconox.com.
Does Alconox, Inc. offer validation consultants to provide validation tech support?
Answer:
Yes, Alconox can provide valuable consulting and information to medical device manufacturers. Our critical cleaning experts can discuss validation concerns such as techniques for determining acceptable residual levels and analytical methods for residue quantitation.
Alconox, Inc. supplies detergents to medical device manufacturing companies that require exacting levels of quality control and technical service. Alconox, Inc. provides support for regulatory-compliant cleaning validations which includes lot number traceability of all cleaners and ingredients, cleaner toxicity and reactivity/degradation information, shelf-life testing, residue sampling, detection methods and written cleaning procedures.
Discuss worst case critical cleaning issues with the experts. 'Ask Alconox' at cleaning@alconox.com.
Tuesday, September 23, 2008
Pharma Cleaning Validation - Residue Detection Method Selection
Question:
What are the residue detection methods that can be used for cleaners? Does Alconox provide pharmaceutical validation information?
Answer:
A pharmaceutical cleaning validation involves residue detection method selection. Residue detection method selection for cleaners can involve specific methods for specific cleaner ingredients such as; high performance liquid chromatography (HPLC), ion selective electrodes, flame photometry, derivative UV spectroscopy, enzymatic detection and titration, or it can involve non-specific methods that detect the presence of a blend of ingredients such as: total organic carbon, pH, and conductivity. The FDA prefers specific methods, but will accept non-specific methods with adequate rationales for their use. For investigations of failures or action levels, a specific method is usually preferable. The later section of this document lists references to several methods for each cleaner brand.
Yes, Alconox, Inc. has compiled a directory of residue detection methods for all Alconox brand detergents and pharmaceutical cleaning validation information. To access this information, visit http://www.alconox.com/static/section_top/gen_cleanval.asp.
What are the residue detection methods that can be used for cleaners? Does Alconox provide pharmaceutical validation information?
Answer:
A pharmaceutical cleaning validation involves residue detection method selection. Residue detection method selection for cleaners can involve specific methods for specific cleaner ingredients such as; high performance liquid chromatography (HPLC), ion selective electrodes, flame photometry, derivative UV spectroscopy, enzymatic detection and titration, or it can involve non-specific methods that detect the presence of a blend of ingredients such as: total organic carbon, pH, and conductivity. The FDA prefers specific methods, but will accept non-specific methods with adequate rationales for their use. For investigations of failures or action levels, a specific method is usually preferable. The later section of this document lists references to several methods for each cleaner brand.
Yes, Alconox, Inc. has compiled a directory of residue detection methods for all Alconox brand detergents and pharmaceutical cleaning validation information. To access this information, visit http://www.alconox.com/static/section_top/gen_cleanval.asp.
Friday, September 19, 2008
Corrosion Inhibition
Question:
Does Alconox provide any information on corrosion inhibition in Alconox brand cleaners?
Answer:
Yes! Corrosion during cleaning is accelerated by the same things that accelerate cleaning: heat, aggressive chemicals, time, and agitation. In approximate order of importance, to reduce metal corrosion concerns, use less heat, lower pH detergents, shorter cleaning time, and less agitation. In general use the mildest pH detergent to limit metal corrosion. Higher pH detergents such as SOLUJET or DETO-JET have special corrosion inhibitors that allow their use with aluminum. SOLUJET and CITRAJET have inhibitors that allow their use on a broad range of sensitive metals without leaving filming amine residues. In approximate order of importance, in general to reduce plastic corrosion, use less aggressive cleaners that have less solvent or surfactant character or use lower concentrations of those cleaners, use lower cleaning temperatures, use less contact time, and finally use less agitation.
To read more, please visit this page.
Does Alconox provide any information on corrosion inhibition in Alconox brand cleaners?
Answer:
Yes! Corrosion during cleaning is accelerated by the same things that accelerate cleaning: heat, aggressive chemicals, time, and agitation. In approximate order of importance, to reduce metal corrosion concerns, use less heat, lower pH detergents, shorter cleaning time, and less agitation. In general use the mildest pH detergent to limit metal corrosion. Higher pH detergents such as SOLUJET or DETO-JET have special corrosion inhibitors that allow their use with aluminum. SOLUJET and CITRAJET have inhibitors that allow their use on a broad range of sensitive metals without leaving filming amine residues. In approximate order of importance, in general to reduce plastic corrosion, use less aggressive cleaners that have less solvent or surfactant character or use lower concentrations of those cleaners, use lower cleaning temperatures, use less contact time, and finally use less agitation.
To read more, please visit this page.
Tuesday, September 16, 2008
Solar Module Manufacturing
Question:
Which Alconox detergents can best clean glass or metal that has a photovoltaic surface?
Answer:
Thin film solar module manufacturing requires scrupulously clean substrates in order to optimize the yield of efficient photovoltaic surface. By optimizing yield, the cost of producing solar electricity can be reduced so that it can reach parity with the cost of producing electricity on the grid as other forms of energy rise cost. Thin film photovoltaic cells are made by vapor deposition of silicon (Si) or Cadmium/Telluride (CdTe) layers on transparent metal oxide coated glass superstrates; or by vapor deposition of copper, indium, gallium selenide (CIGS) on thin metal film. In either case, the glass or metal must be clean and free of particulates and oils that will interfere with proper film deposition and electrically isolated solar cell formation. When glass superstrates are laser scribed to form isolated cells, any particulates on the bare glass or oxide coatings can result in poorly formed scribe barriers that cause short circuits and inefficient performance of the resulting cell. Substrates must be clean before and after laser scribing. Detojet detergent is recommended for use in cleaning glass and coated glass substrates before or after laser etching. Large conveyorized spray and roller brush washing units are used. Citrajet is recommended for metal substrate cleaning. Detojet and Citrajet are available from the global distribution network of Alconox, Inc. dealers.
To read more about Detojet and Citrajet, visit www.alconox.com.
Which Alconox detergents can best clean glass or metal that has a photovoltaic surface?
Answer:
Thin film solar module manufacturing requires scrupulously clean substrates in order to optimize the yield of efficient photovoltaic surface. By optimizing yield, the cost of producing solar electricity can be reduced so that it can reach parity with the cost of producing electricity on the grid as other forms of energy rise cost. Thin film photovoltaic cells are made by vapor deposition of silicon (Si) or Cadmium/Telluride (CdTe) layers on transparent metal oxide coated glass superstrates; or by vapor deposition of copper, indium, gallium selenide (CIGS) on thin metal film. In either case, the glass or metal must be clean and free of particulates and oils that will interfere with proper film deposition and electrically isolated solar cell formation. When glass superstrates are laser scribed to form isolated cells, any particulates on the bare glass or oxide coatings can result in poorly formed scribe barriers that cause short circuits and inefficient performance of the resulting cell. Substrates must be clean before and after laser scribing. Detojet detergent is recommended for use in cleaning glass and coated glass substrates before or after laser etching. Large conveyorized spray and roller brush washing units are used. Citrajet is recommended for metal substrate cleaning. Detojet and Citrajet are available from the global distribution network of Alconox, Inc. dealers.
To read more about Detojet and Citrajet, visit www.alconox.com.
Friday, September 12, 2008
Types of Aqueous Cleaners
Question:
What are the different types of aqueous cleaners?
Answer:
There are mineral-acid cleaners that range in pH from 0-2 which remove heavy scales. Mild acid cleaners that range in pH from 2 – 5 ½ , remove inorganic salts, water, and soluble metal complexes. Neutral cleaners range in pH from 5 ½ 0 8 ½ and remove light oils and small particles. Mild alkaline cleaners range in pH from 8 ½ - 11 and remove oils, particulates and films. Alkaline cleaners range in pH from 11 – 12 ½ and remove oils, fats, and proteins. Corrosive alkaline cleaners that range in pH from 12 ½ - 14 remove heavy grease and soils. The Aqueous Cleaning Handbook p 17
Alconox, Inc. manufactures acid, neutral, mild alkaline and corrosive alkaline cleaners for use in various critical cleaning applications. To read more about Alconox brand cleaners, visit www.alconox.com.
What are the different types of aqueous cleaners?
Answer:
There are mineral-acid cleaners that range in pH from 0-2 which remove heavy scales. Mild acid cleaners that range in pH from 2 – 5 ½ , remove inorganic salts, water, and soluble metal complexes. Neutral cleaners range in pH from 5 ½ 0 8 ½ and remove light oils and small particles. Mild alkaline cleaners range in pH from 8 ½ - 11 and remove oils, particulates and films. Alkaline cleaners range in pH from 11 – 12 ½ and remove oils, fats, and proteins. Corrosive alkaline cleaners that range in pH from 12 ½ - 14 remove heavy grease and soils. The Aqueous Cleaning Handbook p 17
Alconox, Inc. manufactures acid, neutral, mild alkaline and corrosive alkaline cleaners for use in various critical cleaning applications. To read more about Alconox brand cleaners, visit www.alconox.com.
Tuesday, September 09, 2008
Food contact surface cleaners
Question:
What are two Alconox brand cleaners are low foaming and USDA approved for cleaning food contact surfaces?
Answer:
Alconox, Inc. manufactures cleaners for food contact surfaces with no interfering residues. Citrajet, Low-foaming Liquid Acid Cleaner and Alcojet, Low- Foaming Powdered Detergent are designed for cleaning food contact surfaces.
To learn more about Citrajet, please visit http://www.alconox.com/downloads/pdf/techbull_citrajet.pdf.
To learn more about Alcojet, please visit
http://www.alconox.com/downloads/pdf/techbull_alcojet.pdf.
What are two Alconox brand cleaners are low foaming and USDA approved for cleaning food contact surfaces?
Answer:
Alconox, Inc. manufactures cleaners for food contact surfaces with no interfering residues. Citrajet, Low-foaming Liquid Acid Cleaner and Alcojet, Low- Foaming Powdered Detergent are designed for cleaning food contact surfaces.
To learn more about Citrajet, please visit http://www.alconox.com/downloads/pdf/techbull_citrajet.pdf.
To learn more about Alcojet, please visit
http://www.alconox.com/downloads/pdf/techbull_alcojet.pdf.
Thursday, September 04, 2008
Cleaning Aluminum with Alconox, Powdered Precision Cleaner
Question:
What are the concerns when cleaning aluminum with Alconox?
Answer:
Alconox is widely used to clean aluminum, however we are aware that on extended contact time (typically measured in days) at elevated temperature, a chelate blush can form on aluminum. A chelate blush is a white crusty irregular deposit of aluminum edetate, a reaction between the aluminum and the chelating agent in Alconox.
When cleaning aluminum, it is assumed that the aluminum has been exposed to air and has formed the typical aluminum oxide layer prior to cleaning. If the aluminum has been recently machined and has oils that protect it from the air, then you can have a very active surface under the oil that will form a dark oxidation with Alconox or just about any uninhibited cleaner when the oil is removed under immersion without any air present to form the more passive aluminum oxide surface before being exposed to the cleaner.
If recently machined aluminum must be cleaned and it cannot be allowed to air passivate, then a cleaner that contains appropriate metasilicate inhibitors such as Solujet, Detojet, Alcojet or Tergajet must be used. With the use of these kinds of cleaners, on machined aluminum that does not have the oxide layer formed yet, you get points of aluminosilicate formed only at active sites on the aluminum surface. You do not get a film of any kind and this does not change the electrical, structural or bonding characteristics of the aluminum and is not generally considered to be a problem.
To learn about Alconox brand cleaners, visit www.alconox.com.
What are the concerns when cleaning aluminum with Alconox?
Answer:
Alconox is widely used to clean aluminum, however we are aware that on extended contact time (typically measured in days) at elevated temperature, a chelate blush can form on aluminum. A chelate blush is a white crusty irregular deposit of aluminum edetate, a reaction between the aluminum and the chelating agent in Alconox.
When cleaning aluminum, it is assumed that the aluminum has been exposed to air and has formed the typical aluminum oxide layer prior to cleaning. If the aluminum has been recently machined and has oils that protect it from the air, then you can have a very active surface under the oil that will form a dark oxidation with Alconox or just about any uninhibited cleaner when the oil is removed under immersion without any air present to form the more passive aluminum oxide surface before being exposed to the cleaner.
If recently machined aluminum must be cleaned and it cannot be allowed to air passivate, then a cleaner that contains appropriate metasilicate inhibitors such as Solujet, Detojet, Alcojet or Tergajet must be used. With the use of these kinds of cleaners, on machined aluminum that does not have the oxide layer formed yet, you get points of aluminosilicate formed only at active sites on the aluminum surface. You do not get a film of any kind and this does not change the electrical, structural or bonding characteristics of the aluminum and is not generally considered to be a problem.
To learn about Alconox brand cleaners, visit www.alconox.com.
Tuesday, September 02, 2008
Alcotabs
Question:
What is the shelf life of Alcotabs?
Answer:
The shelf life of ALCOTABS Tablet Pipet Detergent (Mfr. Cat. Nos. 1500-1, 1500) has been increased from 730 days (2 years) to 1095 days (3 years) effective as of May14, 2008. Shelf life extension studies determined that the functionality of the ALCOTABS is consistent for a period in excess of 3 years.
To view the updated technical bulletin, download our PDF.
What is the shelf life of Alcotabs?
Answer:
The shelf life of ALCOTABS Tablet Pipet Detergent (Mfr. Cat. Nos. 1500-1, 1500) has been increased from 730 days (2 years) to 1095 days (3 years) effective as of May14, 2008. Shelf life extension studies determined that the functionality of the ALCOTABS is consistent for a period in excess of 3 years.
To view the updated technical bulletin, download our PDF.