Conclusion

Isolators are the sole future of high-potency drug processing in the pharmaceutical industry. Isolators represent the only existing technology that guarantees the best protection for operators and the high sterility-assurance level of injectable products. The fully isolated system provides total containment for all material handling with the highest capital costs offset by lower operating cost.

Use of isolators has grown with the correspondent increase in the discovery and use of high-potency drugs. The industry is understanding the advantages of isolators even if regulations do not officially require their use. The isolator will be the only technology allowed by regulatory authorities for manufacturing high- potency drugs under safe conditions. The advantages offered by isolators compared with traditional cleanrooms is pushing the industry to choose isolator technology for future investments in high-potency manufacturing (1–10).

Note: A "qualified person" is a designation in European pharmaceutical regulations (Article, 51 EU Directive 2001/83/EC for Medicinal Products for Human Use).

References

1. FDA, Guidance for Industry—Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice Appendix 1: Aseptic Processing Isolators (Rockville, MD), Sept. 2004, available at http://www.fda.gov/CbER/gdlns/steraseptic.pdf, accessed Oct. 13, 2008.

2. FDA, Pharmaceutical CGMPS for the 21st Century—A Risk-based Approach (Rockville, MD), available at http://www.fda.gov/Cder/gmp2004/GMP_finalreport2004.htm, accessed Oct. 13, 2008.

3. J. Lysford and M. Porter, "Barrier Isolation History and Trends," presented at the International Society for Pharmaceutical Engineering Washington Conference: Barrier Isolation Technology, Washington DC, June 2004.

4. ISO, ISO 14644-7 Cleanrooms and Associated Controlled Environments: Part Z: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators and Mini Environments) (Geneva, Switzerland) Oct. 2004.

5. PDA, Technical Report No. 34 Design and Validation Of Isolator System for Manufacturing and Testing of Health Care Products, June 2001.

6. PIC/S, PI 014-1: Recommendation—Isolator Used for Aseptic Processing and Sterility Testing (Geneva, Switzerland), June 2002.

7. EUDRA, EU GMP: Eudra I: Medicinal Products for Human and Veterinary Use: Good Manufacturing Practices Vol. 4, Annex 1, p. 66.

8. "FDA Q&A on Barrier Isolation—The FDA Answers Your Questions on Barrier Isolator Technology," Pharm. Eng. 27 (2), 2007.

9. L. Francis, "Containment Considerations for Toxic and Potent Aseptic Liquid Filling," Pharm. Eng. 27 (3), 2007.

10. J. Agalloco, J. Akers, and R. Madsen, "Choosing Technologies for Aseptic Filling: Back to the Future, Forward to the Past, Pharm. Eng, 27 (1), 2007.

For a comparison of conventional cleanrooms, restricted access barrier systems, and isolators, see the online exclusive, "A Comparison of Conventional Cleanrooms, Restricted Access Barrier Systems and Isolators".