Clean Room Design

To achieve USP 797 compliance, pharmacies must provide a sterile drug compounding suite. This suite construction must meet the standards of an ISO Class - 7 controlled- air environment [Clean room].

Other design parameters are also tightly regulated. For instance, this regulation specifies that drug compounding must be performed within an ISO Class-5 hood environment enclosed within the larger compounding suite’s buffer zone. Compounding aseptic isolators [CAI] may be operated outside the Class 7 environment under specific operating requirements.

Pharmacy Directors who are neither trained environmental microbiologists nor experienced clean room architects can ulitize Microtest's consulting services. Our project managers deliver expert clean room design and workflow analysis services.

Microtest will assist you in locating reliable, local vendors providing cost-effective clean room design/renovation and construction services.