A Quality Management System necessitates forethought into the myriad number of variables that must be managed in a Corrective Action, Preventative Action (CAPA) approach. A well thought out cleaning, disinfection and decontamination program for the pharmaceutical manufacturing environment is one of the fundamental components of a successful operation. In order to manufacture safe and quality products, one must satisfy the strict demands of the federal and international regulatory agencies as well as the exact demands of their customers. This means understanding what types of contamination damages your products as well as all sources of those contaminates.
The cleanroom environment is under constant attack by potentially fatal contaminants generated by three major factors: cleanroom personnel, the endless stream of supplies, materials and equipment brought into the cleanroom environment daily, and the manufacturing processes that take place within the cleanroom.
A properly designed cleanroom staffed by personnel who understand and follow proper cleanroom protocols can keep these particles to extremely low levels. But extremely low levels many not be good enough. Particles impregnated with microorganisms travel along air currents in the cleanroom and most are carried back to the air filtration system for entrapment and removal. However, many of the particles tend to settle on the surfaces they come into contact with. Some of these are at or near critical production areas.
Settling particles are affected by numerous physical forces such as static, ionic attraction, humidity, gravity and Van der Waal forces -- to mention just a few -- which cause them to bond to surfaces in such a manner that their removal becomes very difficult, at best. This is where a specialized crew of technical cleaners who are properly educated, trained and equipped can remove environmental contamination threats to your process and product.
Personnel Training is mandatory
Training is the essential element in developing a good cleanroom cleaning technicians. Workers must have a thorough understanding of exactly what a cleanroom is, how it functions and what purpose it serves. Equally important is imparting knowledge of exactly what kinds of contamination causes problems for their specific process and products. This way explaining what contamination needs to be eliminated and why is easy to comprehend. Technical cleaners do not need a degree in particle science or microbiology, but some knowledge of contamination ID’s and characterization,microorganisms and habitat, particle size, movement and adhesion qualities is essential if they are expected to perform their duties at the required levels. Without this basic knowledge, all subsequent training means nothing.
First focusing training on the contamination burden introduced by each of us is a good way to establish personal awareness and self-responsibility. Instilling good personal hygiene habits and teaching the proper gowning procedures are perhaps the two most important aspects of this initial training phase. These should be followed closely by a comprehensive understanding of proper cleanroom protocols.
Only after trainees have mastered the above, should they be introduced to the methodology -- or good science -- of cleaning and disinfecting a cleanroom. This methodology includes defining a list of prohibited materials that must never be taken into a cleanroom and the introduction of accepted chemicals, supplies, materialsand equipment. Proper instruction in precise cleaning procedures and verification of cleanliness levels round out a proper cleanroom cleaning and disinfection methodology.
Tools, materials and chemical selection are keys to success
The cleaning needs of any particular cleanroom are not necessarily related to the class of cleanroom being serviced. Each case requires individual analysis of not only the cleanroom`s cleanliness requirements (class of cleanroom), but also of the amount and type of contaminants generated within the cleanroom by manufacturing processes and personnel. The gowning requirements of cleanroom personnel must also be taken into consideration, along with the airflow characteristics of the cleanroom. If a cleanroom has underperforming utility needs, overcompensation in contamination control protocols will be required.
It is important to note that not all areas or surfaces within a specific cleanroom will require the same cleaning methodologies and frequency of cleaning. Once the cleaning needs are established, thought should be given to the types of cleaning tools, materials and chemicals that should be used in a cleanroom environment.
Caution should be used when purchasing a vacuum. Just because a vacuum claims to be HEPA filtered, does not mean that it performs to ANSI standards. Most of the vacuums that can be purchased at the local hardware store would raise eyebrows with the FDA and other Quality auditors. A cleanroom vacuum filters the exhaust with a HEPA filter. There seem to be only three brands that occupy this market, Nilfisk, Tiger Vac and Hako Minuteman.Central vacuum systems are also used, but not as much in the pharmaceutical industry. The absence of exhaust airflows in the cleanroom itself is very attractive. The length of the hose and the ribbed structure of it, render it almost impossible to keep clean.
Portable vacuum systems are used in cleanrooms that don`t have a central system and as a supplemental system for those who do. The selection of a portable vacuum system to fit the task is essential. Portable backpack-type vacuums with the proper HEPA filtration have become a popular choice for cleanroom use. They allow more mobility for hard to reach areas, such as behind process equipment, and in areas such as ceilings, high walls and stairs. Care must be taken with these vacuums, as the exhaust air flow happens at work station level and will cause turbulence that could be problematic.It`s imperative to maintain all filters and ancillary equipment for all vacuum systems in proper working order and cleanliness. Ancillary equipment includes hoses, nozzles and other precision cleaning attachments of various sizes and shapes. Equally important is the selection of materials used in these attachments. You wouldn`t want to use a material that could scrape the surface being cleaned, thereby creating additional particle generation.