Parenteral drug association

Polyethylene and polystyrene are examples of plastics subject to environmental stress cracking. Crack resistance tests have shown that surfactants, alcohols, organic acids, vegetable and mineral oils, and ethers provide an active environment for stress cracking of polyethylene. Table 6 lists typical sterile devices and plastic materials used to fabricate them, while Tables 7-9 list the potential effects of sterilization processes on polymeric materials. The effect of gamma irradiation on elastomeric closures has been studied by the Parenteral Drug Association [15]. 

Glass containers for small volume parenteral products Factors for selection and test methods for identification. Parenteral Drug Association Inc., Technical Methods Bulletin No. 3, 1982. 

Source Parenteral Drug Association. Technical report No. 29, Points to consider for cleaning validation, PDA Journal of Pharmaceutical Science and Technology 52 Nov-Dec Supplement (1998). 

Title 21 Code of Federal Regulations (21 CFR Part 11), Electronic Records Electronic Signatures, FDA, 2003 (http //www.fda.gov). Validation/compliance documents found under the Parenteral Drug Association (PDA) (http //www.pda.org). 

Guideline on PDA (Parenterals Drug Association Inc.) of Validation of Pharmaceutical and Biopharmaceuticals, February 1993. 

Technical Report No, 26, Sterilization Filtration of Liquids, Parenterals Drug Association, Inc. 1998. 

Parenteral Drug Association, Technical Report No. 21, Bioburden Recovery Validation, Vol. 44, No. S3 (PDA, 1990)... 

Extractability tests prescribed by other regulatory agencies [FDA, Parenteral Drug Association (PDA)] for closures for drug packaging [69,70] are also limited to the amount of extractable residues or tests to evaluate the in vivo reaction of the extractable residue when the material fails in the in vitro tests. 

Parenteral Drug Association (PDA) (1998), Pharmaceutical package integrity, Technical Report 27, PDA Bethesda, MD. 

The Parenteral Drug Association (PDA) has developed a technical paper on the validation of laboratory data acquisition system [9]. 

Parenteral Drug Association (PDA), Validation and Qualification of Computerized Laboratory Data Acquisition Systems (LDAS), Technical Paper 31, 2000. 

Loftus, B. T. Validation and stability, meeting of Parenteral Drug Association, 1978. 

Technical report no. 26 from the Parenteral Drug Association [63] identifies the following factors that should be part of selecting and qualifying a filter for use as a product sterilizing fdter ... 

Validation of Steam Sterilization Cycles, technical monograph no. 1. Parenteral Drug Association (1978). 

Validation of Dry Heat Processes Used for Sterilization and Depyrogenation. technical report no. 3. Parenteral Drug Association (1981). 

Pflug, I. J. Monitoring the sterilization process. In Syllabus for Introductory Course in the Microbiology and Engineering of Sterilization Processes. 2nd ed. Philadelphia Parenteral Drug Association, pp. 19.2-19.4 (1978). 

Validation of Aseptic Filling for Solution Drug Products, technical monograph no. 2. Philadelphia Parenteral Drug Association, pp. 16-21 (1980). 

PDA. Validation of Computer-Related Systems, Technical Report No. 18. Bethesda, MD Parenteral Drug Association (1995). 

Schicht, H. H. International Standards on Cleanroom Technology and Their Impact on the Pharmaceutical Industry—An Update. Parenteral Drug Association, Basel Congress (2002). 

Parenteral Drug Association. Moist Heat Sterilization in Autoclaves Cycle Development, Validation and Routine Operation. PDA technical report 1, revision, draft 11. Bethesda, MD, May 2001. 

Agalloco, J. Validation—yesterday, today and tomorrow. Proceedings of Parenteral Drug Association International Symposium, Basel, Switzerland, Parenteral Drug Association, 1993. 

A few years ago, the Parenteral Drug Association (PDA) Task Force on Cleaning issued a Points to Consider document [10] that enumerated various types of s amplings currently in use in the industry. They were (at that time)... 

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