Cleanroom contamination can arise from several known sources, such as: water, air ventilation (HVAC) and surfaces, however most root causes of contamination are being traced back to personnel working in cleanrooms. This blog will discuss contamination risk minimization of compounded sterile preparations (CSPs) namely introduced by people, and existing control measures such as, cleanroom garbing and good hygiene practices and personnel behaviour, to eliminate or contain and control microbial presence in critical controlled environments.
So why should we be concerned about the presence of microorganisms in the compounding industry? Simple answer is that we should be deeply concerned of the negative impact these invisible creatures may cause. As compounders, it should be our responsibility to understand the complication microorganisms could cause and compromise a sterile compounding process if we are careless or unaware. Consequently, control measures set by regulatory bodies have been enforced to help to minimize and contain their presence in critical controlled environments of the sterile compounding process.
There are a number of control measures, which form part of cleanroom management, to contain and minimize microbial presence in critical controlled areas. The main synergistic principles that need to be considered when compounding a sterile product are to:
Contain people with sterile garments;
Contain the product using unidirectional laminar airflow cabinets, and
Contained people and product are located inside a controlled background environment.
The typical number of cells dwelling on human body parts such as the scalp, arms, hands, thigh, back, armpit or feet, are in the millions. Furthermore, millions of skin flakes shed from the body and act as “microbial carriers” and gravitate them to critical locations that may pose a significant risk to product. It is obvious that good gowning and hygiene practices should be considered to contain and eliminate microbial presence by having sound garbing practices and applying good hygiene practices prior to entry into these critical areas. To achieve this level, guidance and recommendations provided by local and global regulatory bodies should be followed, together with a comprehensive training program promoting good hygiene practices (such as proper hand-washing technique) and on-going assessments to ensure garbing practices are always followed.
Garbing practices need to be adequate to exclude all microorganisms from the richest areas and the temperature of the controlled environment for personnel needs to be comfortable. Garments used need to be an effective barrier and the following adequate practices need to be followed;
Garment suppliers should be certified and garbs are to be supplied sterile;
Jewellery should not be allowed inside cleanrooms;
Hairnet or beard net should not be exposed and tucked in underneath outer garment;
Hands underneath to be properly washed with soap and warm water prior to garbing with hand wash stations to be located in the room leading into the compounding room, and
once garbed and in cleanrooms hands are to be periodically sanitized with sterile alcohol.
Along with garbing, policies regarding personnel health must be implemented to further protect the controlled environment and CSP. Personnel must show no signs of unhealthy symptoms (such as constant runny nose, itchiness, sneezing or coughing) and no cuts or signs of bleeding with band-aids. In the current state of health, it is important that these infectious disease policies are re-communicated to staff.
Ultimately, it is critical that the relationship between people and the controlled environment where CSPs are made is managed so as to minimise risk. These mitigation/control factors should be captured through procedures based on regulatory guidance and if possible, with advice from subject matter experts in Microbiology. A comprehensive training plan needs to be in place with on-going assessments that tackle the importance of garbing practices to reduce the risk of product contamination; and garbs used are of the best quality and obviously sterile.
About the Author - Alfred Campos
Alfred Peter Campos graduated from the Western Sydney University with a B Sc majoring in Microbiology and currently employed by Verita Pharma as a Microbiologist/Sterile Compounding Manufacturing Leader. Alfred has over 15 years of Microbiology experience in various industries spanning the Dairy, Pharmaceutical, Medical Devices and the Sterile Compounding Industries.