December 2018

Can an Isolator still be used without a Cleanroom?

Can an Isolator still be used without a Cleanroom?

Can an Isolator still be used without a Cleanroom? The answer is complicated. Under the current USP 797 guidelines, a compounding aseptic isolator may be used as a substitute for a cleanroom if it is certified to meet ISO 5 under dynamic conditions. Usually, the certifier will conduct particle tests and airflow studies while a …

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Cleanroom Training and Evaluation

As cleanroom experts, we also provide on-site clean room training.   This on-site training can be implemented in several ways. We have done short courses, that largely involves lecture only in as little as one day on-site. Depending on the number of people, a full training and testing class can take as long as two …

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Exposure to Hazardous Materials during Shipping and Receiving

Whether isolator or clean room based working areas, if were talking about both sterile and hazardous sterile preparations we recognize the first source of contamination and risk of Exposure to Hazardous Materials. The first known, is actually outside of the clean room and is the pre-cleaning station. In the hazardous drug area we like to …

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