Today, many facilities are conducting internal surface sampling of their cleanrooms in addition to their biannual cleanroom certification. To remain compliant, pharmacies must develop a robust environmental monitoring plan that ensures sterility and cleanliness of their compounding areas as well as proper documentation of SOPs and results. Below are some tips on how to develop your sampling program.
Identify Sampling Locations: Target any critical areas such as ISO 5 PECs, ISO 7 Buffer or Chemo Areas, and ISO 8 Ante Rooms. Sample high-touch or high-traffic areas. Sample near any sterile compounding activities.
Determine Sampling Frequency: Surface sampling is required by USP <797> at regular intervals but monthly is highly recommended. Air sampling is performed every 6 months by a certification company, like Medical Technology Associates.
Selecting Appropriate Methods: Use contact plates for surface sampling. Tryptic Soy Agar promotes the growth of bacteria, while Sabouraud Dextrose Agar promotes the growth of mold. Contact Plates can be purchased here. Follow incubation guidelines within <USP 797>.
Establish Action Levels and Responses: Set microbial levels based on ISO classifications. Develop a procedure for documenting, investigating, and addressing results beyond acceptable limits. It is recommended that any growth is sent to a third party, like LAB 797, for identification. Identification helps with determining the source of error and developing an action plan.
Document and Review: Keep records of sampling results and corrective actions. Look for trends in sampling. Regularly review your plan to adapt to any changes within your facility.
With a thorough sampling program, facilities can continue to ensure compliance. Reach out to LAB 797 if you have questions on developing a program. We are happy to help!