| Risks in the manufacturing of “potent drugs” as well as heightened requirements for Quality Assurance in sterility testing and the aseptic processing environment make the implementation of barrier technologies more and more an obligation.
The following are typical barrier technology systems:
- Restricted Access Barrier Systems
(RABS)
- Isolators for sterility testing in microbiological laboratory and for aseptic and “potent drug” manufacturing in compounding and filling
- Air locks for personnel and material in manufacturing and microbiological laboratory
- Containment systems for product and
operator / environmental protection
In the simplest case, filling lines are protected by Restricted Access Barrier Systems units
(RABS) limiting intervention to gloves.
The implementation of their technology means nearly complete isolation of the process from the environment and a nearly ideal protection of products and operators. These chambers represent “clean rooms” which have to be qualified as such according to international GMP requirements (EMEA and FDA). For these systems
Valicare proposes a qualification package, taking into account the specific conditions for your “isolation system”.
Valicare offers specific services concerning the GMP compliant decontamination cycle development. Our personnel
is very familiar with the technologies and required steps for establishing an effective and validatable cycle, and
is intimately familiar with the process of vaporised hydrogen peroxide
(VHP) decontamination.
References:
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ISO 14 644-7: Cleanroom and associated controlled environments: separative device: clean hoods, glove boxes, isolators and micro environments
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ISO 13 408-1 and –2 : Aseptic processing of health care products
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EU GMP annex 1
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PIC/S Recommendations on the isolator used for Aseptic Processing and Sterility Testing (PI 014-2)
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