Question:
What is immersion manual cleaning?
Answer:
Manual cleaning can be done in-place on manufacturing equipment or at a sink or washroom where disassembled pieces of equipment, tools and utensils are brought for cleaning. Often brushes, abrasive pads, scrapers, buckets, spray bottles, or other appropriate equipment is used for manual cleaning. A good manual cleaning procedure will specify any pre-rinsing, the cleaner concentration, the order which parts of a particular piece of equipment should be cleaned and the rinsing procedures. The advantage of manual cleaning is that it is relatively simple and the operator can give special attention to difficult-to-clean areas or residue until clean criteria is achieved. The disadvantage is that it can take longer, has the cost of human labor, and is very directly subject to human error.
To find the right Alconox aqueous critical cleaner for your manual cleaning method, please visit this page.
Thursday, May 28, 2009
Tuesday, May 26, 2009
Immersion Clean-in-Place (CIP)
Question:
What is immersion clean-in-place (CIP)?
Answer:
Pilot scale and smaller manufacturing tanks, blenders and mixers can be cleaned by completely filling all the pipes and equipment with cleaning solution, possibly while gently running any agitators available in the equipment. A successful validation of this cleaning process will define the concentration of the cleaner, the contact time, the level of agitation and temperature of the cleaning solution required to successfully clean the tank. This cleaning method is used in older large manufacturing tanks that do not have integrated spray CIP systems. The advantage of immersion CIP cleaning is that is simple and does not require a carefully engineered spray CIP system. The disadvantage is that it typically takes longer because the equipment, such as a mixer, would have to be filled, heated and drained rather than the faster cycles obtained by using much smaller quantities of cleaning solution as in a spray CIP systems. Additionally, only the areas that are in contact with the cleaning solution get cleaned and usually some manual cleaning of tanks and mixers on the areas above the fill line has to be performed.
To find the right Alconox aqueous critical cleaner for your CIP method visit Alconox.com.
What is immersion clean-in-place (CIP)?
Answer:
Pilot scale and smaller manufacturing tanks, blenders and mixers can be cleaned by completely filling all the pipes and equipment with cleaning solution, possibly while gently running any agitators available in the equipment. A successful validation of this cleaning process will define the concentration of the cleaner, the contact time, the level of agitation and temperature of the cleaning solution required to successfully clean the tank. This cleaning method is used in older large manufacturing tanks that do not have integrated spray CIP systems. The advantage of immersion CIP cleaning is that is simple and does not require a carefully engineered spray CIP system. The disadvantage is that it typically takes longer because the equipment, such as a mixer, would have to be filled, heated and drained rather than the faster cycles obtained by using much smaller quantities of cleaning solution as in a spray CIP systems. Additionally, only the areas that are in contact with the cleaning solution get cleaned and usually some manual cleaning of tanks and mixers on the areas above the fill line has to be performed.
To find the right Alconox aqueous critical cleaner for your CIP method visit Alconox.com.
Thursday, May 21, 2009
Spray Clean-In-Place (CIP)
Question:
What is spray clean-in-place (CIP)?
Answer:
Spray CIP involves spraying or re-circulating the initial flush, wash, and rinse solutions under pressure, with proper adjustments of time, temperature, and cleaner concentration through the pipes and spray balls to clean large internal areas of the equipment without having to fill them completely with solution. Efficient cleaning of pilot and large scale mixers, tanks and blenders can be achieved by distributing flush, wash and rinse solutions on the upper surfaces at pumping rates equal to 2.0-2.5 gallons-per-minute (gpm) per foot of circumference for vertical vessels, or 0.2-0.3 gpm per square foot of internal surface for horizontal and rectangular tanks. Piping systems can be effectively cleaned via recirculation at flow rates producing a velocity of 5 feet per second or more in the CIP circuit's largest diameter piping. The advantage of spray CIP is that it can rapidly clean large pieces of equipment using minimal amounts of cleaning solution as well as minimal amounts of energy to heat the solutions and rinse water. The disadvantage of spray CIP is that it requires very careful engineering design to assure successful cleaning. If there are difficult-to-clean places that the automated system fails to clean, manual cleaning may be required. If a new difficult-to-clean product is made in production equipment that has a spray CIP system and it cannot successfully clean the new product, then possibly a new cleaning agent may be required or a change to immersion cleaning or manual cleaning may be necessary.
To find the right Alconox aqueous critical cleaner for your CIP method visit Alconox.com.
What is spray clean-in-place (CIP)?
Answer:
Spray CIP involves spraying or re-circulating the initial flush, wash, and rinse solutions under pressure, with proper adjustments of time, temperature, and cleaner concentration through the pipes and spray balls to clean large internal areas of the equipment without having to fill them completely with solution. Efficient cleaning of pilot and large scale mixers, tanks and blenders can be achieved by distributing flush, wash and rinse solutions on the upper surfaces at pumping rates equal to 2.0-2.5 gallons-per-minute (gpm) per foot of circumference for vertical vessels, or 0.2-0.3 gpm per square foot of internal surface for horizontal and rectangular tanks. Piping systems can be effectively cleaned via recirculation at flow rates producing a velocity of 5 feet per second or more in the CIP circuit's largest diameter piping. The advantage of spray CIP is that it can rapidly clean large pieces of equipment using minimal amounts of cleaning solution as well as minimal amounts of energy to heat the solutions and rinse water. The disadvantage of spray CIP is that it requires very careful engineering design to assure successful cleaning. If there are difficult-to-clean places that the automated system fails to clean, manual cleaning may be required. If a new difficult-to-clean product is made in production equipment that has a spray CIP system and it cannot successfully clean the new product, then possibly a new cleaning agent may be required or a change to immersion cleaning or manual cleaning may be necessary.
To find the right Alconox aqueous critical cleaner for your CIP method visit Alconox.com.
Tuesday, May 19, 2009
Automated Clean-in-Place (CIP)
Question:
What is automated clean-in-place (CIP)?
Answer:
Spray and immersion are two kinds of automated clean-in-place systems used typically for cleaning pharmaceutical manufacturing equipment. In both these systems there is a primary water source that can be heated, if necessary, that is used to make up the cleaning solutions and as rinse water before and after the cleaning cycles. An external tank can be used for mixing up and storing the cleaning solutions, although sometimes the manufacturing tank is used for this purpose. A separate external tank for holding the rinse water can also be employed as well as a second source of water if the final rinse requires purified water such as water-for-injection (WFI) or deionized (DI) water. There will be pumps and piping connecting these external CIP tanks to the manufacturing equipment that needs to be cleaned. A water conservation system can be installed that pumps the final rinse water into the cleaning solution dilution tank in order to use that water for the first cleaning cycle in the next automated CIP run. There will be automated controllers to run the pumps and control the dosing of cleaning agent and water. These controllers can be full or semi-automated programs that require operator intervention at key steps in the process. There are often monitoring systems that assure that the process is being done according to the program and that all parts of the system are functioning correctly. The automated equipment has sensors and data recorders to assist with the documentation of the cleaning and can often create reports that will become part of the batch log to document that the cleaning was done correctly for regulatory compliance. Automated CIP systems can be permanently integrated into a set of manufacturing tanks, or they can be on mobile skids that are moved from tank system to tank system. Typically, the best results with automated cleaning are achieved when the automated CIP system is integrated into the original design of the manufacturing system. Often an existing tank must be retro-fitted with an automated CIP system. This retro fit can involve either spray CIP or immersion CIP systems.
To find the right Alconox aqueous critical cleaner for your CIP method visit Alconox.com.
What is automated clean-in-place (CIP)?
Answer:
Spray and immersion are two kinds of automated clean-in-place systems used typically for cleaning pharmaceutical manufacturing equipment. In both these systems there is a primary water source that can be heated, if necessary, that is used to make up the cleaning solutions and as rinse water before and after the cleaning cycles. An external tank can be used for mixing up and storing the cleaning solutions, although sometimes the manufacturing tank is used for this purpose. A separate external tank for holding the rinse water can also be employed as well as a second source of water if the final rinse requires purified water such as water-for-injection (WFI) or deionized (DI) water. There will be pumps and piping connecting these external CIP tanks to the manufacturing equipment that needs to be cleaned. A water conservation system can be installed that pumps the final rinse water into the cleaning solution dilution tank in order to use that water for the first cleaning cycle in the next automated CIP run. There will be automated controllers to run the pumps and control the dosing of cleaning agent and water. These controllers can be full or semi-automated programs that require operator intervention at key steps in the process. There are often monitoring systems that assure that the process is being done according to the program and that all parts of the system are functioning correctly. The automated equipment has sensors and data recorders to assist with the documentation of the cleaning and can often create reports that will become part of the batch log to document that the cleaning was done correctly for regulatory compliance. Automated CIP systems can be permanently integrated into a set of manufacturing tanks, or they can be on mobile skids that are moved from tank system to tank system. Typically, the best results with automated cleaning are achieved when the automated CIP system is integrated into the original design of the manufacturing system. Often an existing tank must be retro-fitted with an automated CIP system. This retro fit can involve either spray CIP or immersion CIP systems.
To find the right Alconox aqueous critical cleaner for your CIP method visit Alconox.com.
Friday, May 15, 2009
Cleaning methods for all phases of pharmaceutical manufacturing.
Question:
Considering that there are different phases in pharmaceutical manufacturing, bench scale R&D, pilot studies and full-scale manufacturing, what are the best critical cleaning methods for each?
Answer:
According to FDA rationale, cleaning equipment is meant to be designed to "prevent contamination or adulteration of drug products". Typically pharmaceutical operations require transition from bench scale R&D to pilot studies to full-scale manufacturing. Each transitional stage requires careful consideration of changes to the processing equipment and cleaning techniques. In general, the size of the equipment gets larger as each stage is encountered. In this regard, manual and soak-cleaning procedures tend to be adequate for bench-scale equipment, whereas pilot and large-scale manufacturing process equipment usually requires clean-in-place (CIP) cleaning by automated spray or immersion systems and/or by manual cleaning. All stages of development and production may use manual cleaning or machine washers to clean various parts of equipment or utensils. If feasible, it is desirable to clean the pharmaceutical equipment in place without having to disassemble or move it in order to rapidly get the equipment back into service.
Alconox has an aqueous critical for manual, soak and clean-in-place (CIP) cleaning methods. To find the right Alconox aqueous critical cleaner for your method visit Alconox.com.
Considering that there are different phases in pharmaceutical manufacturing, bench scale R&D, pilot studies and full-scale manufacturing, what are the best critical cleaning methods for each?
Answer:
According to FDA rationale, cleaning equipment is meant to be designed to "prevent contamination or adulteration of drug products". Typically pharmaceutical operations require transition from bench scale R&D to pilot studies to full-scale manufacturing. Each transitional stage requires careful consideration of changes to the processing equipment and cleaning techniques. In general, the size of the equipment gets larger as each stage is encountered. In this regard, manual and soak-cleaning procedures tend to be adequate for bench-scale equipment, whereas pilot and large-scale manufacturing process equipment usually requires clean-in-place (CIP) cleaning by automated spray or immersion systems and/or by manual cleaning. All stages of development and production may use manual cleaning or machine washers to clean various parts of equipment or utensils. If feasible, it is desirable to clean the pharmaceutical equipment in place without having to disassemble or move it in order to rapidly get the equipment back into service.
Alconox has an aqueous critical for manual, soak and clean-in-place (CIP) cleaning methods. To find the right Alconox aqueous critical cleaner for your method visit Alconox.com.
Thursday, May 07, 2009
Cleaning Quartz Tubing
Question:
I need to clean small quartz tubing (I.D. = .035" O.D. = .069") that is sealed at one end.
Answer:
Alconox, Inc recommends Liquinox, a mild alkaline cleaner that is phosphate free. Since the ID is a little less than 1 mm, rinsing will be a bit tricky. The ideal cleaning scenario would be to use a syringe inserted up into the end of the tube, first flushing with warm 1% Liquinox, followed by adequate amounts of rinsing with DI water. If this is not practical, as long as the tube is not too long (less than 6 mm) then if soaked upright in ultrasonics, would probably work but an adequate rinse must be carried out as well using the ultrasonic tank.
Click here for Liquinox technical bulletin.
I need to clean small quartz tubing (I.D. = .035" O.D. = .069") that is sealed at one end.
Answer:
Alconox, Inc recommends Liquinox, a mild alkaline cleaner that is phosphate free. Since the ID is a little less than 1 mm, rinsing will be a bit tricky. The ideal cleaning scenario would be to use a syringe inserted up into the end of the tube, first flushing with warm 1% Liquinox, followed by adequate amounts of rinsing with DI water. If this is not practical, as long as the tube is not too long (less than 6 mm) then if soaked upright in ultrasonics, would probably work but an adequate rinse must be carried out as well using the ultrasonic tank.
Click here for Liquinox technical bulletin.
Tuesday, May 05, 2009
Checking for Residues
Question:
What is the FDA consensus standard or industry standard for checking for residues?
Answer:
The FDA does not give any guidance on preferred methods for detecting residues. For investigations they prefer selective methods such as high performance liquid chromatography (HPLC), but they certainly accept the use of non-selective methods such as total organic carbon (TOC), see this page from the Center for Drug Evaluation and Research. In our experience, in medical device residue detection, the most commonly used technique is TOC, at least as far as detergent residues are concerned. The Technical Information Reports (TIR-12 and TIR-30) from the AAMI gives some references to methods used for specific types of residues other than detergents.
The technical experts at Alconox, Inc have taken the guess work out of selecting the appropriate analytical detection methods for all of its brands. To review the Directory of cleaner residue detection methods for each Alconox detergent visit Alconox.com.
What is the FDA consensus standard or industry standard for checking for residues?
Answer:
The FDA does not give any guidance on preferred methods for detecting residues. For investigations they prefer selective methods such as high performance liquid chromatography (HPLC), but they certainly accept the use of non-selective methods such as total organic carbon (TOC), see this page from the Center for Drug Evaluation and Research. In our experience, in medical device residue detection, the most commonly used technique is TOC, at least as far as detergent residues are concerned. The Technical Information Reports (TIR-12 and TIR-30) from the AAMI gives some references to methods used for specific types of residues other than detergents.
The technical experts at Alconox, Inc have taken the guess work out of selecting the appropriate analytical detection methods for all of its brands. To review the Directory of cleaner residue detection methods for each Alconox detergent visit Alconox.com.
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