Parenteral society

Sterilization of freeze-dryers. Technical Monograph No. 5. The Parenteral Society, 6 Frankton Gardens, Stratton St. Magaret, Swindon, Wiltshire, 1994... 

The Parenteral Society (PS). Technical Monograph No. 7, Leak Testing of Freeze Dryers. Wiltshire PS (1995). 

The Parenteral Society [2.34] recommends the following criteria for integrity testing ... 

The Parenteral Society. Integrity Testing of Freeze-dryer Inlet Filters, Technical Monograph No. 8... 

The Parenteral Society Specification and Validation of Freeze-Dryers No. 9. 

The Use of Process Simulation Tests in the Evaluation of Processes for the Manufacture of Sterile Products, Technical Monograph No. 4 The Parenteral Society, Swindon, Wiltshire, UK, 1993. 

The use of process simulation tests for the manufacture of sterile products, uk parenteral society technical monograph number 4. 

There are no standard methods for verifying microbiological integrity of container-closure systems. Documents such as that published by the Parenteral Society in 1992 ° and the PDA in 1998 may be helpful in relating microbiological integrity to secondary physical tests, but they do not specify detailed microbiological test methods. 

The Prevention and Detection of Leaks in Ampoules, Vials and Other Parenteral Containers Parenteral Society Technical Monograph No. 3 Parenteral Society Swindon, UK, 1992. 

Parenteral Society (2001) Microbiology Special Issue. Eur Parenteral Sci, 6(4). 

Parenteral Drug Association (PDA) and British Parenteral Society (BPS) Technical reports and guidelines prepared by industry on various parenteral topics, e.g., Sterile Pharmaceutical Packaging, compatibility and stability (PDA) PDA Archive containing research papers, technical reports and conference proceedings available on CD-ROM updated annually... 

Joanne Broadhead, PhD, MRPharmS, manages a small team of formulation scientists at AstraZeneca R D Charnwood in the development of solid and parenteral products. Her experience includes two years as a formulation scientist for creative BioMolecules (Hopkinton, Mass., USA) prior to joining AstraZeneca in 1996. Dr. Broadhead is a member of the American Association of Pharmaceutical Scientists, the Parenteral Drug Association and the Parenteral Society. 

Various guidelines, including those on general or current GMP (CGMP), are available related to specific aspects of the above from both official organisations, such as the FDA, and specialised societies such as the UK-based Parenteral Society and the US-based PDA. 

Container/closure seal integrity has been reviewed by the Parenteral Drug Association (1983) and the Parenteral Society (1992). Variation in the overall height of the combined vial and closure will result in different closure-seal forces being applied at the crimping head. Quality control tests are proposed such as the dye intrusion challenge, liquid loss or bacterial... 

The Parenteral Drug Association [19] recommends 30 min for aseptic filling rooms the Parenteral Society [16] recommends 4 h. Whyte and Niven [20] have argued that the viability on agar plates of microorganisms commonly found in room air is little affected by desiccation and quote allowable exposure periods... 

Parenteral Society (1990). Technical Monograph No, 2. Environmental Contamina-ton Control Practice, Swindon, U.K. Parenteral Society. 

The sterilization efficiency of the inlet venting Alters has to be assured by regular integrity tests. The filter integrity test should be performed automatically with the relevant data documented by the control system the principle is shown in Figure 20. The criteria for an integrity test given by the Parenteral Society [10] are summarized as ... 

---