(EM) is a process of microbial testing that detects trends of colonies in a controlled environment or cleanroom. Poor EM is an invitation for microbes to camp on
surfaces, personnel, and even air
. Depending on the manufacturer, contamination can have varying impacts, however one result remains constant. Accumulating microbes means loss of time, money, and products. With growing colonies around every corner, taking risks with EM could mean recalls, delays, shortages, and loss of public reputation. With EM so critical in today’s manufacturing business, more in the industry are seeking the help of outsourced testing services.
Cleanrooms are designed for easy upkeep. Hard floors and surfaces, fabricated from smooth material, lacking crevices to trap particles are crucial. Design is but a single key in keeping Good Manufacturing Practices, which are ensured by the FDA to give manufacturers a consistent and controlled production system (1,2). If the Critical Control Points in a facility are compromised, a clean area and environment can be scarcely maintained. Critical Control Points are enacted to prevent or eliminate present hazards that arise from the production process (3).
Sure Bio-Chem Laboratories caters to these occurrences for new and established businesses alike. For start-ups, SBL can provide
to create high standards of GMP for your staff. As for established facilities, SBL’s certification is relevant for re-certification following facility renovations. The cleanroom’s integrity depends not only on the hygienic practices of the employees, but environmental monitoring.
The FDA requires facilities to have EM these systems and others to prevent microbial contamination and facilitate public well being. Good Manufacturing Practices can prevent FDA warning letters, however few EM programs will always meet their expectations. SBL is an expert in Environmental Monitoring, and can establish new EM plans or support existing plans. Based on your needs, SBL can advise what micro sampling methods and sampling locations your facility should focus. With SBL monitoring your cleanroom, we provide frequency trend reporting and establish alert and action limits. SBL interprets your results and support investigations for out-of-spec results.
to contact us and request a service!
References
1.
http://www.ispe.org/gmp-resources
2.
http://www.fda.gov/food/guidanceregulation/cgmp/
3.
http://www.fda.gov/Food/GuidanceRegulation/HACCP/ucm2006801.htm#defs
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Sure-BioChem Laboratories
Sure-BioChem Laboratories offers top-notch analytical testing for various industries. Our advanced lab and expert team ensure reliable, quality results. We're committed to excellence, helping clients meet high standards in environmental, food, and pharmaceutical testing.
Headquarters:
1000 Atlantic Avenue
Camden, NJ 08104
PHONE: 888-398-7247
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