Recontamination
After Cleaning, Sanitization and Sterilization if the Product, Material, equipment or components are contaminated again with undesirable substance due to inappropriate Use, handling, storage or any environmental issues is called Recontamination.
Prevention of Recontamination in Sterile and non sterile manufacturing:
- After cleaning & sanitization of Equipment it should be dried adequately to prevent the growth of Microbes.
- Clean Equipment Hold time (CEHT) should be established to determine the maximum hold time after cleaning.
- Equipment & Material must be stored in adequate control condition. Environmental conditions ( Temperature, Humidity, Differential pressure, Particle count etc.) must meet the acceptance criteria.
- Air Quality must meet the clean room criteria on a continuous basis. The HEPA filter integrity, Pressure drop in AHU, differential pressure etc should be monitored by a Robust EMS/ BMS system to assure that air Quality isn't a source of Contamination/ Recontamination.
- The final rinse of Equipment is usually done with Purified/ WFI grade Quality Water. The water quality might be a potential source of Contamination if the Critical Quality parameters aren't adequately controlled and monitored. Online and offline monitoring of Water Quality should be done on a regular basis.
- Personnel Gown must be washed, dried, Stored and used as per Validated procedure to prevent the contamination
- Disinfectant used in the area and equipment must be Validated that is used up to declare self life.
- If sterilized items aren't used immediately after sterilization, these should be stored using appropriately sealed packaging and maximum hold time should be established.
- Where material, equipment, components and ancillary items are Sterilized in sealed packing and transferred to Grade A, High care and control system should be in place to protect the items from recontamination.
- Material, equipment, components and ancillary items that aren't not a direct or indirect product contact part and necessary for aseptic processing but can't be sterilized, an effective and Validated disinfection and transfer system should be in place to prevent recontamination.
- The item to be sterilized other than product in sealed container, should be dry , packed in protective barrier system which allows removal of air and penetration of steam and prevents recontamination after sterilization.
Contamination or Recontamination is always a risk in the pharmaceutical industry. Taking adequate preventive measures can help maintain high standards of quality and comply with statutory regulations.
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