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home > pmps > autumn 2003 > environmental monitoring practices and regulations for the sterile manufacturer
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Environmental Monitoring Practices and Regulations for the Sterile Manufacturer

Manufacturing of pharmaceutical products and medical devices requires an environment in which the number of airborne particles is controlled, and which is constructed and used in a manner to minimise the introduction, generation and retention of such particles. Other relevant parameters such as temperature, humidity, airflow filtration, and velocity and room pressurisation, are controlled as necessary. A formal programme is established and maintained to assess these factors and their effect on the microbiological quality of the process and product. Due to minor differences in the requirements of regulating agencies (see Tables 1-3), the programme should be established with reference to those regulatory requirements in the country in which the products will be sold.

Luckily, a plethora of standards and guidelines are now available to help manufacturers. In the US the FDA's Quality Systems Regulation states '...the manufacturer shall establish and maintain procedures to adequately control these environmental conditions', and '...procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality'. IEST has promulgated several ISO standards (see Table 4), incorporating information from the now defunct Federal Standard 209E. In addition, the FDA's Aseptic Processing Guideline (1987) discusses where to monitor non-viable particulate and states that samples should be taken ̉not more than one foot away from the worksite'. In 2001 PDA published technical report No. 13, Fundamentals of an Environmental Monitoring Program, a very complete summary of the fundamentals.


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By Anne Booth, Quality GMP and Sterilisation Specialist at Booth Scientific

Anne F Booth is a Quality GMP and Sterilization Specialist with over 20 years' of experience in the field of medical device manufacturing. She has worked for three medical device manufacturers as Sterilisation Services Manager/Director and a contract steriliser as Director of Validation. In each of these positions she provided technical support in the development, validation and management of both GMP compliance and sterilisation programmes. Ms Booth's experience has also included establishing sterilisation support testing labs and environmental monitoring programmes, developing quality manuals and performing audits, validating cleanrooms and manufacturing processes, and recommending cleaning and sterilisation programmes for reusable devices. She established an independent consulting business, Booth Scientific Inc, in 1994 which has provided optimal GMP and sterilisation programmes for more than 50 medical device and pharmaceutical manufacturers.

She holds a MS degree in Cellular Zoology/Biochemistry from the University of Michigan and a BA degree in Biology from Wilson College. She is a Member of the American Society of Quality, RAPS, PDA, ISPE and AAMI where she is a Member of the EtO sterilisation, EtO Residual, Packaging, Radiation, Microbiological Methods and Reuse standards working groups. Ms Booth is also widely published.

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