During potent compound safety evaluations and certifications I often observe the misuse of powered air-purifying respirators (PAPRs) in the pharmaceutical industry, and frequently get I would asked a lot of questions regarding their use. Frequent areas of misuse and common issues include:
- A belief that a PAPR will protect you against any airborne concentration of an active pharmaceutical ingredient (API). In the pharmaceutical industry, most PAPRs have a rated protection factor of 1000. If you are handling a potent compound with a category 3, 4 or 5 classification your ability to properly contain a highly potent active pharmaceutical ingredient may not be the case. I’ve found many instances where the measured airborne concentration of an active pharmaceutical ingredient has exceeded the 1000 times protection factor…be aware. Of course this requires that your company has either prepared a potent compound classification report or a potent compound occupational exposure limit. In addition, be prepared to prove your level of protection to an OSHA compliance officer.
- Not following the pre-use inspection protocols for PAPRs. Your employees need to know this from memory. If they can’t articulate how to inspect the respirator before use then your company is opening itself up to some OSHA regulatory liability, and more importantly to an occupational exposure issue.
- A misunderstanding of respiratory protection cartridge change schedules. Needs to be clearly spelled out in the written respiratory protection program. Often a huge gap.
- Decontamination issues between different active pharmaceutical ingredient products. More of a cGMP issue, but still very important.
These issues can be resolved by ensuring that all personnel have been provided with thorough environmental, health and safety training that is specifically tailored to the issues regarding potent compound safety certification and training. Based on these issues, everyone in the biotechnology, pharmaceutical, and medical device industry needs a compliance management software solution to assist them.