Preventing Biological Contaminations – the Importance of Regulatory Compliant Pest Control
Oren Golan, Lugassy-Golan, Kiryat-Gat, Israel
Pharmaceutical and medical devices manufacturer do everything to avoid chemical contamination from many possible sources: buildings, raw materials and equipment, but have you ever thought of biological contaminations that can come from pests?
21 CFR 211.56 refers to sanitation and puts emphasis on pest control to prevent infestation in the facility.
The Integrated Pest Management (IPM) approach is the latest method to prevent infestation and composed of 4 steps:
1. Knowing the most common pests and their biological cycle.
2. Early prevention – actions to be taken to prevent entry of pests and prevent infestation in our facility (can be raw materials entry, packaging materials which may have been stored in rooms already infested. can be facility’s external area like industry or agricultural areas and the facility itself like cracks and holes, lights etc that attracts flying insects, Rodents and other vermin).
3. Monitoring – put correct equipment in correct places to monitor the presence, type and quantity of pests in classified and non classified areas
4. Act – actions to be taken according to monitoring records results and sanitation inspections are necessary in the pharmaceutical industry. That action must be without chemicals/pesticide at all.
According to GMP rules, FDA and CE guides – controlled areas, such as clean rooms must be protected at all time, without using chemicals.