Maintaining sterility in an ISO certified compounding facility is simple when standard operational procedures and protocols are followed. Minimizing the chance of an environmental crisis requires implementing steps to mitigate contamination including utilizing proper disinfectants, monitoring pressure gauges, monitoring for particulates, room temperature, and airflow.
Neglecting sterility has a range of consequences, the most serious of which is criminal. This 2018 FDA release outlines how serious performing sterile compounding in a non-sterile room can be for staff and customers. Less severe microbial or particulate contamination may result in product disposal and recall, lost time and profits and pharmacy reputation.
Written to help quantify and manage airborne particles contamination worldwide, The International Organization for Standardization (ISO) has published two cleanroom standards, ISO 14644 Cleanrooms and associated controlled environments and ISO 14698 Cleanrooms and associated controlled environments – Biocontamination control. ISO 14644 specifies the classification of air cleanliness for concentration of airborne particles in cleanrooms and clean zones. ISO 14698 establishes a methodology for assessing and controlling biocontamination when cleanroom technology is applied.
Sources of contamination
According to a recent cleanroom maintenance study, a major source of pharmacy contamination is induced by humans. Employees may introduce contaminants to clean rooms from their hair or skin, or by wearing non-sterile garments that do not meet particulate requirements referenced in ISO 9073 Part 10. Before products are brought into the anti-room prior to entering the clean room, they should be removed from their outer box packaging and the inner bags should be wiped clean with 70% isopropyl alcohol. Verify that each item has the correct packaging and inspect for damage. If appropriate look for Gamma Radiation sterilization and Ethylene Oxide indicators.
Other causes of contamination include poor filtration, incorrectly calibrated or non-working monitoring equipment, product shortages, and power outages. An employee mistake, such as spraying an air filter with disinfectant, could cause the filer to lose effectiveness leading to clean room contamination.
Responding to an environmental crisis
What if your pharmacy has been operating normally, without an incident for months and all protocols have been followed? Despite this, an environmental crisis, trigged by an excursion occurs. How should you respond?
Following these steps ideally get your pharmacy operational quickly and efficiently following an environmental crisis. In the meantime, avoid an event by keeping cleanrooms up to date with disinfectant cleaning rotations, and maintain detailed cleaning and product logs.
Since 2013, DiNovo Pharmacy & Packaging Provisions has been a leader in delivering cleanroom consumables, disinfectants, medical devices, and cold chain shipping solutions to the compounding and specialty pharmacy marketplace. As an educational resource, coupled with top global manufacturer partnerships, DiNovo is able to help pharmacies drive efficiency, manage costs, and enhance compliance to help guide you through a constantly changing pharmacy marketplace.