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Isolation technology for research and development applications: from concept to production
A K Krishna1, S A Lodhi, M R Harris
1Parke-Davis Pharmaceutical Research, Division of Warner-Lambert Company, Morris Plains, New Jersey 07950, USA. Aravind.Krishna@wl.com
Pharmaceutical Development and Technology
|December 8, 2000
Summary
A new parenteral manufacturing facility using isolator technology offers a reliable, cost-effective alternative for sterile product R&D. This approach, utilizing vaporized hydrogen peroxide (VHP) for sanitization, is ideal for small batch production.
Area of Science:
- Pharmaceutical Manufacturing
- Sterile Product Development
- Containment Technology
Background:
- Traditional cleanroom technology presents challenges for sterile parenteral manufacturing.
- Research and Development (R&D) settings require flexible and reliable sterile production solutions.
- Isolator technology offers a contained environment for sterile operations.
Purpose of the Study:
- To design, construct, and commission a prototype parenteral manufacturing facility utilizing isolator technology.
- To validate the efficacy of vaporized hydrogen peroxide (VHP) for isolator sanitization.
- To assess the performance and suitability of the isolator-based facility for R&D sterile manufacturing.
Main Methods:
- Installation of closed isolators for sterile product handling and manufacturing.
- Evaluation of VHP distribution and sanitization effectiveness using chemical, biological, and swab testing.
- Performance qualification through media fills to demonstrate sterile process integrity.
Main Results:
- Established operating conditions for routine VHP sanitization of isolators.
- Media fills confirmed the sterile integrity of the manufacturing process, with identified handling deficiencies corrected.
- The isolator-based facility proved reliable and cost-effective for small batch sterile parenteral production.
Conclusions:
- Isolator technology provides a viable and economical alternative to cleanrooms for parenteral manufacturing in R&D.
- VHP sanitization is an effective method for maintaining aseptic conditions within isolators.
- While successful for small batches, closed isolator technology has limitations for large-scale automated production.
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