We all know OEL (occupational Exposure limits ) are comming into effectiveness across globe. Here we have a specific case of handling Sterile parenterals in Freeze dried Form or Powder form or Liquid form and they may be a Biological or an Antibiotic (Sensitive product) or a Cytotoxic product- " What are immediate steps to be taken prevent the exposure of an (Operator) to these agents if vial/ampoule breaks on a Manual or Automated Visual/ampoule inspection Table/Machine? Or what are containment required to prevent such exposures?
Immediately the operator should spray the inacivation agent on that surface and followed by cleaning.
The following preventive measures should be taken for operator and environment safety:
The best one is using Negative (in case of powder processing) and Positive (Incase of liquid) isolators (Minimum ISO classIV as per ISO 10648-2)
Using Pressure suites (for personnel safety) and scrubber (for environment safety).
Creating High pressure zones (Ex. Processing area should be negative than non processing areas)
Establishing the inactivation procedures.
Validating the OEL levels (0.1 microgram per cubic meter is the altemate limit).
Using BIBO (Bag IN Bag Out) HEPA and pre filters for safe change during cleaning and replacement.
Training to staff and operators.
Thanks with Regards,
Your reply is for processing of Solids/Liquids.
Please refer back to my question: How to prevent during inspection of Vials or ampoules during visible inspection of Cytotoxic products when they break on Inspection table?