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Sterility – when is it right for your cleanroom?

Production consumables can be used in a whole range of healthcare and pharmaceutical facilities including compounding pharmaceutical rooms, aseptic manufacturing lines, and biotechnology laboratories. in these instances, it is fundamental that the consumables are sterile so as not to contaminate the end product.

STERILITY IS NOT VISIBLE

The sterility of a product cannot be assumed; it must be proven, consequentially meaning that non-sterility is not immediately noticeable. The organisms of concern – bacteria, viruses, fungi, and spores – are only visible through a microscope; there is a heavy dependence on the consumer/supplier to adhere to current Good Manufacturing Practices (cGMP) and validated procedures to provide true sterility of supplied consumables.

ASSISTANCE FROM STANDARDS ORGANIZATIONS TO ACHIEVE STERILITY

The process of producing validated sterile wipers (either dry or pre-saturated) is simple but consists of many actions that must be meticulously followed in order to adhere to guidelines. Fortunately, standards organizations such as the American National Standards Institute (ANSI), the Association for the Advancement of Medical Instrumentation (AAMI), and the International Organization for Standardization (ISO) provide guidance on the recognised procedures for sterility validation. It becomes clear that wipers are treated as if they were medical devices for the purpose of producing a validated sterile product.

WHAT LEVEL OF STERILITY IS REQUIRED FOR WIPERS?

Manufacturing facilities insist on a 1 part per million level of sterility. This means that only one wiper out of a sample of one million wipers can be non-sterile. This can be achieved by gamma irradiation of wipers, or x-ray irradiation which is a ever-growing irradiation technique in the pharmaceutical industry. 

INSIST ON DOCUMENTATION

Typical data requirements for validated sterile wipers are:

• Data to prove that the radiation level to achieve an SAL of 10-6 will not cause physical damage to the wipers or compromise their performance in any other way.
• Wiper bioburden data from standard production lots on a quarterly basis.
• Data to demonstrate that the number of non-sterile units meets the validation method requirement when subjected to the validation dose.
• Data on the maximum and minimum irradiation dose mapping for each production lot of validated sterile wipers. Similarly, data on the irradiation loading configuration (within the irradiation chamber) for each production lot of validated sterile wipers.
• Data on packaging integrity of the irradiated product at pre-determined intervals. Only when all of this data is provided by the vendor with each production lot can the wipers be marketed and sold as “Validated Sterile Wipers.”

SUMMARY

When it has to be sterile, it has to be validated. And if it has to be validated, it has to be documented. Insist on the documentation.

 

Contact our sales team at sales@Cesltd.uk.com or call us at 01793512505 for more information on our cleanroom and our sterile products. 

Two men wearing coveralls in a cleanroom

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