Pharmacy compliance is a daunting task in today’s regulatory environment. EOC1 has been helping our customers meet pharmaceutical clean room qualification standards over the last 14 years with our pharmacy compliance consulting services. We can help wade through the myriad of standards and regulations set forth by ISO, USP, JCAHO, OSHA, FDA and State Boards of Pharmacy. These different bodies have varying requirements that are specific to pharmacy primary and secondary engineering controls, as well as employee validation requirements.
Contact EOC1 to learn more about our pharmacy compliance services.
Primary Engineering Controls
Primary engineering controls in the healthcare setting include pharmacy hoods specific to controlling aseptic and hazardous environments. These environments require operation and subsequent certification of hoods such as clean benches, biological safety cabinets, compounding aseptic isolators (CAI), compounding aseptic containment isolators (CACI) and Class I hoods.
Secondary Engineering Controls
Secondary engineering controls include cleanrooms suited for the specific operations and where the concentration of airborne particles is controlled to specific limits. Room classifications are specified in ISO-14644-1: "Cleanrooms and associated controlled environments-Part I-Classification of air cleanliness." Rooms are classified into ISO Classes 1 through 9. ISO Class 5 through 8 are specific to pharmacies as referenced in USP chapters 797 and 800.
In addition to engineering controls, employee validation and environmental monitoring is also required as part of pharmacy compliance services. Employee validation is required in aseptic compounding with media-fill testing and fingertip sampling being performed. Additionally, biological and chemical sampling is needed to validate gowning and cleaning protocols and to provide a safe compounding environment for employees.
Let EOC1 help you meet your pharmacy compliance program needs with proper certification, testing and validation of your facility.