The discussion will now focus on the sources of contamination encountered in cleanroom manufacturing, and briefly discuss some of ways that these contaminants are minimised and why this minisization is important. The major sources of contamination in cleanroom manufacturing are:
In some cleanroom manufacturing environments a fairly large number of chemicals are used. Each individual chemical could be a source of contamination. To keep chemicals clean and particulate free highly purified variants are required. These will need to be delivered in clean, non-corrosive containers, transported ‘cleanly’ and not cross contaminated.
Contamination control depends on a reliable filter system. A malfunctioning filter can introduce contaminants into a controlled environment. Filters need to remove impurities from the process stream but avoid transferring impurities that could wind up on a device’s or product’s surface. The filters themselves must be manufactured and packaged in a controlled environment.
Repairing or replacing inadequate filters can be costly. In particular, custom filters can be expensive and may take weeks or months to be delivered, so adequate planning is a must. Following good protocols will keep filters working right and minimize premature change-outs, with the associated expenses for parts and labor as well as disruption and potential contamination.
Preventive maintenance is obviously the first step to ensure that a cleanroom’s filters function properly, and that the amount of time and money spent on them is minimal.
Meticulous hiring practices for cleanroom personnel include screening potential operators for physical characteristics such as: smoker hiring policy, overweight or obese personnel, facial hair, sensitivity to heat, cold and humidity, and seasonal allergies including skin allergies. Also, when evaluating personal skills and language skills, the human resources department must also evaluate potential cleanroom candidates for mental characteristics such as claustrophobia. Recommendations for personnel behavior in the cleanroom are found in IEST-RP-CC027.2, “Personnel, Practices and Procedures in Cleanrooms and Controlled Environments.”
Contamination poses a significant risk to technical processes, experiments or production activities, as well as to the individuals involved. Unguarded proliferation of contamination can quickly lead to product damage, yield reduction, product recalls and other outcomes highly detrimental to business. Products in a range of industries are recalled due to ineffective contamination control systems.
Contamination control is the generic term for all activities aiming to control the existence, growth and proliferation of contamination in certain areas. Contamination control may refer to the atmosphere as well as to surfaces, to particulate matter as well as to microbes and to contamination prevention as well as to decontamination.
Preventing the growth of microorganisms is essential in most cleanrooms that deal with food, biologicals, or pharmaceuticals. The best way to combat contamination is by constructing floors without cracks and holes so microorganisms cannot hide and propagate.
Contamination control is easier than detection because you cannot test for every impurity. Even if a product does not come in direct contact with the cleanroom environment, it is still influenced by it. Convection and circulating air can carry particulates and microbes, while handling can transfer residue. Thorough cleaning and disinfection of the environment minimizes the potential for contaminants to adversely affect product quality.
Who is best suited to perform housekeeping in a clean environment? Those that work in the cleanroom, a special in-house cleaning team, or an outside cleaning service? There are advantages and disadvantages to each, say cleaning supply representatives.
Personnel in critical areas may be monitored for microbial contamination utilizing contact plates. The contact plates monitor areas of the body that may interact with the sterile field or product exposure areas. These may include gloved hands, forearms, or other areas. Personnel monitoring is a good indication of how well personnel are gowning when they enter the clean room. Many companies utilize this testing for proficiency based training programs for clean room personnel.
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