Pharmacy compliance is a daunting task in today’s regulatory environment. EOC1 has been helping our customers meet these needs over the last 14 years. 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.
Primary engineering controls in the healthcare setting include 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 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. 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 compliance needs with proper certification, testing and validation of your facility.