Manual Cleaning

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.

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.

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.

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.

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.

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.

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.

AR coated optics cleaning

Question:
What is Alconox's aqueous cleaner recommendation for cleaning surface of delicate AR coated optics and diffraction gratings from dicing particle contamination?

Answer:
Liquinox Critical Cleaning Liquid Detergent is widely used for cleaning AR (anti-reflective) coated optics. The recommended working concentration is 0.5 -1.0% at ambient temperature, followed by adequate rinsing. For more technical information, review the Liquinox technical bulletin.

Remove Biofilm on SS

Question:
How do I remove biofilm on stainless steel?

Answer:
Alconox's recommendation to remove biofilm on stainless steel is to use a two step process entailing an alkaline cleaner, Solujet, followed by an acidic cleaner, Citrajet. In our experience we get the best results when the first step of 3% Solujet (alkaline cleaner) at 75 deg C for 30 minutes followed by a cursory rinse. Then the second step of 3% Citrajet (acidic cleaner) at 75 deg C for 30 minutes followed by a thorough rinse. Both Solujet and Citrajet are low foaming cleaners.

Additionally, we recommend the intermittent use of Tergazyme, an enzyme cleaner, as a maintenance procedure that will completely remove all dead cells and traces of polysaccharide biofilm. This is beneficial because it in turn slows down the formation of biofilm and allows the regular cleaning cycle (Solujet - Citrajet) to clean effectively for more cycles. It is important to note that Tergazyme is a powder that you typically mix 1% in cool to warm water (35 deg C would be fine, do not exceed 50 deg C - to ensure integrity and activity of the enzyme). Tergazyme is a high foaming cleaner and would not be suitable for a spray-in-air clean-in-place system. You can pump and gently agitate Tergazyme solutions; however you cannot employ high agitation at an air/solution interface without getting excessive foam.

For product technical bulletins and MSDS, visit Alconox.com for easy download.

Aqueous Degreaser

Question:
Do you have an aqueous degreaser to replace chlorinated solvents?

Answer:
Chlorinated solvents clean by solvating residues. Many polar organic and inorganic residues are soluble in chlorinated solvents. The solvents are typically used in baths where the residue is dissolved in to the bath; or the solvents are used with rags or wipes where the residue is dissolved and transferred to the rag or wipe; or in some cases the solvents are used in vapor degreasers where the solvent condenses on to the substrate and drips off in to the tank carrying the residue with it. In all cases, you typically keep cleaning to the point where enough residue is removed and you are now left with clean enough solvent on the substrate. In effect, these solvents are self rinsing. Once cleaning and rinsing are completed, then the last of the solvent evaporates away to dryness.

Aqueous cleaners can quite easily be used to remove polar organic and inorganic residues. In fact depending on what cleaner is used, aqueous cleaners can additionally remove particulates, oxides and a range of non-polar and other organic residues that are not soluble in chlorinated solvents. The method of use and cleaning mechanisms for using aqueous cleaners are quite different from solvent cleaning. Aqueous cleaners work by emulsifying, dispersing, wetting, chelating, dissolving, and saponifying residues. The big difference is that aqueous cleaners need to be rinsed with water. Aqueous cleaners also benefit from using heat, whereas for safety reasons, you usually do not heat chlorinated solvents except in vapor degreasers. You typically need to change the cleaning procedures to switch from a chlorinated solvent to an aqueous cleaner.

If you were using soak tanks to clean with chlorinated solvent, you can typically use a soak tank with warm 1% Liquinox followed by a thorough water rinse to get comparable or better cleaning. If you are using a vapor degreaser, typically you would use a warm or hot 1% Liquinox solution in an ultrasonic tank followed by a thorough water rinse to get comparable or better cleaning. If you were using chlorinated solvents with rags, you can often use rags of warm 1% Liquinox to clean with, followed by whatever best rinse is practical using other rinse water rags or ideally a running water rinse. The kinds of residues that are best removed by chlorinated solvents can typically be readily removed by Liquinox.

One other key difference between aqueous cleaners and chlorinated solvents is that the rinse water used can cause rust on certain kinds of tool steel, mild steel and iron. Since Liquinox is a residue-free cleaner, there are no corrosion inhibiting residues that will survive the rinse process. Once the detergent is rinsed away, any dissolved oxygen in the rinse water can attack the steel and cause rust. Typically rusting will not occur during cleaning, but during rinsing. You can minimize and control any rusting by being sure to rinse with cool ambient temperature water and the drying promptly by a water removing process rather than a water evaporating process. Water removing drying processes include wiping, blowing off with air or gas jets, dipping in isopropanol or other drying solvents. On stainless steel, plastics, ceramics and most other substrates there are not corrosion concerns with mild aqueous cleaners like Liquinox.

For more information, please download the LIQUINOX technical bulletin.

Clean Tough Cosmetic Residues

Question:
What Alconox brands are recommended for cleaning tough cosmetic residues off of manufacturing equipment?

Answer:
Whether you're scrubbing 1,500-gallon kettles or wrestling with plastic tubes and fillers, you need to ensure that the last batch of product you processed really is history. That's where Alconox cleaners come in. Proven detergents such as CITRANOX, TERGAZYME, and ALCONOX wash away your most tenacious cleaning problems-without leaving residues.

CITRANOX excels in removing trace metals and oxides—including titanium dioxide.

TERGAZYME conquers proteinaceous residues.

ALCONOX makes short work of silicon residues and even tackles waterproof mascara in heated immersion cleaning.

Whatever the surface-glass, plastic, metal, or otherwise- Alconox gets it critically clean. Visit us for more information.

Cleaning Cosmetic Operations

Question:
Want to make cleaning cosmetic operations cheaper and more efficient?

Answer:
Alconox can help! Alconox stretches your cleaning budget in two key ways. First, Alconox detergents make your cleaning jobs faster and easier. Scrubbing and rinsing big stainless-steel kettles can take hours.

Alconox can shorten-or even eliminate- manual scrubbing time. And that means saving money. Second, Alconox detergents are highly concentrated for economical use. A little bit of any one of them goes a very long way.

Our experts can help you improve your cleaning procedures, install new procedures, eliminate cross-contamination and ensure compliance with FDA standards. Whatever your cleaning problem, Alconox can help you solve it.

Alconox offers a broad range of powders and liquids for manual, machine, clean-in-place, and ultrasonic critical cleaning-all free-rinsing, corrosion-inhibiting, and biodegradable.

Visit for more information.

Removing DNA

Question:
What does Alconox recommend for removing DNA from laboratory equipment?

Answer:
Since DNA is stable to alkaline hydrolysis, we recommend testing 1% Citranox Liquid Acid cleaner, pH 2.5. Acids at high temperatures are capable of breaking the DNA molecule into its components. Note the working concentration Citranox recommended here is a starting point, higher concentrations may be required to achieve desired results.

Citranox is liquid acid cleaner for manual, soak and ultrasonic cleaning. It is corrosion-inhibited for glassware, metals, and plastic. Following cleaning with Citranox adequate rinsing with water is required. Citranox has rinse aids that leave no interfering residues on the surface. Before exposing laboratory equipment to any high temperature cleaning or acid cleaning, testing needs to conducted to ensure no damage to equipment surface or substrate. Also, do not mix bleach hypochlorite with Citranox because in sufficient quantities the mixture can form toxic chlorine gas, as they can acidify the bleach solution to below pH 7.

At Alconox we understand how important it is to have clean laboratory equipment, and recognize that any "leftover" DNA (or protein or RNA) could potentially contaminate your next experiment, we suggest that you analytically test for removal of these substances.

Click here for Citranox technical bulletin.

Removing RNA

Question:
What is Alconox's recommendation for removing RNA from laboratory equipment?

Answer:
The basis of our two recommendations for the removal of RNA from laboratory equipment is the principle that alkali can hydrolyze RNA down to mononucleotides.

First recommendation requires adding bleach hypochlorite to 1% Alconox Powdered Precision Cleaner (pH 9.5). Alconox Powdered Precision Cleaner is designed for manual, soak, and ultrasonic tank cleaning of glass, metal, and plastic. No interfering residues will be left behind when rinsed with adequate amounts of RNA-free water. Note the working concentration Alconox recommended here is a starting point, higher concentrations may be required to achieve desired results.

Our second recommendation is 0.5 - 1% Detojet Low Foaming Liquid Detergent pH 12. Detojet is a liquid detergent that can be used manually, in ultrasonic tanks as well as in labware and machine washers. It is corrosion inhibited for glass, metal and plastic and when properly rinsed, leaves no interfering residues. When working with Detojet appropriate safety precautions need to be taken when handling, i.e. safety goggles, gloves, lab coat, etc. Detojet contains KOH and an active chlorine compound, so there is no need to add bleach. The working concentration of Detojet recommended here is a starting point, higher concentrations may be required to achieve desired results.

In either case, Alconox +bleach or Detojet alone, there needs to be cleaner - surface contact time that you will need to determine. Again, the basis of this is alkali can hydrolyze RNA down to mononucleotides, but the alkali needs to come in contact with the surface for 8-16 hours to ensure hydrolysis is complete. This can be accelerated as the temperature of the solution is increased, as overnight at 37 C or 1-2 hours at 65 or 75 deg C. Following contact period with alkali cleaner, adequate rinsing with RNA-free water is required. Also, before exposing laboratory equipment to any alkali for extended periods of time, testing needs to conducted to ensure no damage to equipment surface or substrate.

At Alconox we understand how important it is to have clean laboratory equipment, and recognize that any "leftover" RNA (or DNA or protein) could potentially contaminate your next experiment, we suggest that you analytically test for removal of these substances.

Click here for Alconox technical bulletin.

Click here for Detojet technical bulletin.

Tergazyme Enzyme Cleaner

Question:
Can bleach be added to Tergazyme cleaner?

Answer:
Do not add bleach to Tergazyme, as it will denature the enzyme and render it inactive, in fact the enzyme in Tergazyme will be inactivated within seconds to exposure of 300 ppm hypochlorite, and within 2 minutes to exposure of 3.5 ppm hypochlorite at 100 deg F (37 deg C). Thus, it is not recommended to add bleach to Tergazyme.

Click here for Tergazyme technical bulletin.

Tergazyme for Cleaning Tissue, Blood, Protein

Question:
What does Alconox recommend for cleaning tissue, blood and protein off stainless steel exam and sampling equipment?

Answer:
Tergazyme, enzyme active powdered detergent, is Alconox's recommendation for cleaning tissue, blood and protein from glass, metals and plastics. Tergazyme has been used to clean filter membranes, fermenters and bioreactors as well. This detergent contains a protease that is excellent for cleaning of proteins, tissue, and body fluids and is designed for manual, soak, and ultrasonic cleaning methods. With proper rinsing leaves no interfering residues on the surface. Use at 1% (in solution it is stable for 8 hours). pH 9.5

Click here for Tergazyme technical bulletin.

Detojet Hard Surface Cleaner

Question:
What cleaner would Alconox, Inc recommend for use in glass substrate and module in-process cleaning for large scale glass photovoltaic modules?

Answer:
Alconox, Inc. has introduced Detojet hard surface cleaner for use in glass substrate and module in-process cleaning for large scale glass photovoltaic modules. Detojet can be used in horizontal glass washers that clean the glass panels, followed by rinsing and drying prior to further processing.

Large glass superstrates of transparent conductive oxide coated glass can be cleaned prior to manufacturing and during manufacturing using large horizontal conveyor washers with Detojet cleaner. The combination of dispersants and cleaning agents results in excellent particle control and debris free surface. The dispersants are able to lift particles into solution by overcoming the electrostatic attractions to the hard surfaces and by reducing the hydrophobic tendency of the surface of the particle, thereby rendering it more water dispersible. The cleaning agents remove hydrophobic oily films that can interfere with the particle removing action of the dispersants as well as lead to non-uniform layers during manufacturing.

Detojet is available world wide thru a global network of dealers. See Alconox.com to find a local dealer.

For questions or an aqueous cleaner selection consultation contact the Experts in Critical Cleaning at Alconox, Inc. Email cleaning@alconox.com or call 914 948 4040 for technical support.

Cleaning Thin Film Solar Modules

Question:
How does poor cleaning of thin film solar modules during manufacturing impact cost and yield?

Answer:
Poor cleaning of thin film solar modules can result in increased cost and reduced yield due to module faults from low electrical resistance between cells across laser scribe patterns; short circuits between cells in a module; and reduced steady state efficiency after extended light exposure to a module.

Substrates must be cleaned at the start of manufacturing AND after each significant residue creating process during manufacturing. Need help? Contact the Experts in Critical Cleaning at Alconox, Inc for an aqueous cleaner selection consultation. Email cleaning@alconox.com or call 914 948 4040 for technical support.

Rinse Water

Question:
How do you remove Alconox from rinse waters prior to discharge to the sewer? Will reverse osmosis work effectively in the removal of the Alconox from rinse waters?

Answer:
Alconox is a blend of organic surfactants and inorganic sodium salts of carbonates and phosphates. In principle, reverse osmosis will remove Alconox from water as long as you are using a sufficiently small molecular weight cut off to remove sodium carbonate. Although reverse osmosis would probably work, it might not be the most cost effective approach. Depending on why Alconox needs to be removed and if all of the components of Alconox need to be removed, there might be less expensive separation techniques that would work. To discuss further, please contact technical support at cleaning@alconox.com.

The Aqueous Critical Cleaning Process

Question:
How does aqueous critical cleaning differ from basic cleaning for appearance? How does this apply to the pharmaceutical industry?

Answer:
The aqueous critical cleaning process involves using aqueous cleaners to remove residues from surfaces where the surface cannot function properly without successful cleaning. This is distinguished from simple cleaning for appearance. Aqueous critical cleaning is often used on high value surfaces or surfaces that are used to manufacture high value products. In the case of pharmaceutical manufacturing, the glass, ceramic, plastic, and metal surfaces that make up the tools and equipment used to manufacture pharmaceuticals must be free of any interfering cross contamination. If there is any interfering cross contamination, then the resulting high value pharmaceutical being made can be rendered unusable. There is also the risk that the cross contamination is not detected and contaminated pharmaceuticals can be released for use by humans or animals, thereby putting their health at risk, while exposing the manufacturer to liability. Surely, the aqueous cleaning processes in pharmaceutical manufacturing are some of the most critical of all aqueous critical cleaning processes.

Pharmaceutical process equipment, tools and R&D implements are typically made from fairly robust and cleanable materials such as stainless steel, Teflon, polypropylene, synthetic elastomers, glass and ceramic. Although the materials are relatively easy to clean, the tools and equipment often have difficult-to-clean structures. The kinds of residues found in pharmaceutical manufacturing can include many water-insoluble and otherwise very difficult-to-clean residues. Because of the broad range of formulations available with aqueous cleaners, it is possible to find a cleaner that will work even on the most difficult structures and residues by whatever cleaning method is desired. Not only can you find an effective cleaner, but aqueous cleaners are economical and are relatively safe for the environment and workers.

Learn more about aqueous critical cleaning from the experts who wrote The Aqueous Cleaning Handbook... Request your FREE hardcover copy - a $39.95 value - today by calling (914) 948 - 4040 or email request to cleaning@alconox.com, please include NAME and SHIP TO address.

Visit Alconox.com to learn more about Alconox, Inc aqueous brand cleaners for your high value pharmaceutical manufacturing equipment.