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Quality and Compliance Continuous Environmental Monitoring

Environmental monitoring (EM) is an established method of reducing the risk of contamination of sterile products, and is used by manufacturers in the pharma and associated healthcare industries in the manufacture of advanced medicinal products, as well as in the specialist food industry.

The importance of EM to maintaining the sterility of medicinal products is reflected in the latest EU GMP Annex 1 draft revision, which calls for continuous EM in sectors with stringent environmental control and which carry a risk to public health upon contamination at manufacturing facilities (1).

Why do the latest regulations place such as strong emphasis on continuous EM? The short answer is that it is the most effective way to reduce contamination risk.

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Andy Whittard is the Managing Director at Cherwell Laboratories. Since being appointed MD in 2005 he has overseen significant growth in the business, as Cherwell has focused its offer on cleanroom microbiology solutions for pharma and related sectors. Andy is a Cranfield School of Management Business Growth Programme alumnus, has a background in service and sales, and is part of the second generation in the family business.
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Avantor to Acquire Masterflex; Expands Proprietary Single-Use Offering for Bioproduction

RADNOR, Pa., Sept. 7, 2021 /PRNewswire/ Avantor, Inc. (NYSE: AVTR), a leading global provider of mission-critical products and services to customers in the life sciences and advanced technologies & applied materials industries, today announced that it has entered into a definitive agreement to acquire the Masterflex bioprocessing business and related assets (collectively "Masterflex") of Antylia Scientific.
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White Papers

Syringe siliconization

Gerresheimer AG

Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed, siliconized, sterilized and packaged by the primary packaging manufacturer. They can then be filled by the pharmaceutical companies without any further processing. These days the majority of prefillable syringes are made of glass and the trend looks set to continue. The siliconization of the syringe barrel is an extremely important aspect of the production of sterile, prefillable glass syringes because the functional interaction of the glass barrel siliconization and the plunger stopper siliconization is crucial to the efficiency of the entire system. Both inadequate and excessive siliconization can cause problems in this connection. The use of modern technology can achieve an extremely uniform distribution of silicone oil in glass syringes with reduced quantities of silicone oil. Another option for minimizing the amount of free silicone oil in a syringe is the thermal fixation of the silicone oil on the glass surface in a process called baked-on siliconization. Plastic-based silicone oil-free or low-silicone oil prefillable syringe systems are a relatively new development. Silicone oil-free lubricant coatings for syringes are also currently in the development phase.
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