Cleanroom Standards
Biological Safety Levels (BSLs)
In any cleanroom, the top priority is always the safety of consumers and operators. To avoid any risks, especially when working with hazardous materials, the Centers for Disease Control and Prevention (CDC) have created certain rules for protection and cleanliness: biological safety levels. These regulations ensure any hazardous microorganisms and bio-contaminants are isolated in a…
Read MoreACH Clean Room ISO Standards
What are the ISO Clean Room Standards? ISO Clean Room standards are a set of guidelines established by the International Organization for Standardization (ISO). They focus on the design, construction, and operation of cleanrooms in various industries, including pharmaceuticals, biotechnology, electronics and medical devices. The purpose of these standards is to ensure that cleanrooms meet specific…
Read MoreNAPRA Compliance: Canadian Pharmacy Compounding
What is NAPRA? In Canada, pharmacies are required to comply with the National Association of Pharmacy Regulatory Authorities (NAPRA) standards for high-quality sterile compounding, ensuring preparation quality and safety. Canadian pharmacy compounding facilities must meet certain requirements for their facilities, equipment, employees, and processes in order to be in accordance with these standards. These prerequisites…
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