1. S.S Block, Disinfection, Sterilisation, and Preservation, 5th Edition, Lippincott Williams & Wilkins, Philadelphia, PA, USA, 2000.

2. F.J. Marino and F. Benjamin in Pharmaceutical Dosage Forms: Parenteral Medications, Volume 2, 2nd Edition, Eds., K.E. Avis, H.A. Lieberman and L. Lachman, Marcel Dekker, New York, NY, USA, 1992, 1-54.

3. C.W. Bruch in Sterilisation Technology, Eds., R. Morrisey, and G.B. Phillips, Van Nostrand Reinhold, New York, NY, USA, 1978, Chapter 2, p. 17-35.

4. W. Rogers in Proceedings of the Pharmaceutical Manufactuer s Association (PMA) Seminar Programme on Validation of Sterile Manufacturing Processes , Reston, VA, USA, 1978, Section 6.

5. EN 868-1, Packaging Materials and Systems for Medical Devices which are to be Sterilised General Requirements and Test Methods, 1997.

6. EN868-10, Packaging Materials and Systems for Medical Devices which are to be Sterilised - Part 10: Adhesive Coated Nonwoven Materials of Polyolefines for use In The Manufacture of Heat Sealable Pouches, Reels and Lids - Requirements and Test Methods, 2000.

7. EN ISO 9001, Quality Management Systems - Requirements , 2000

8. ISO 14644-1, Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness, 1999.

9. ISO 14644-2, Cleanrooms and Associated Controlled Environments - Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1, 2000.

10. DIN EN ISO 14644-3, Clean Rooms and Associated Controlled Environments -Part 3: Metrology and Test Methods, 2002. [In German]

11. DIN EN ISO 14644-5, Cleanrooms...