USP Chapter <797> Pharmaceutical Compounding - Sterile Preparations has undergone major revisions (published as of November 1st, 2022). The revisions were driven by a need to improve the state of control and to lower the risk of contamination in sterile compounding facilities. One of the most significant changes to this chapter relates to environmental surface sampling. This includes requirements for demonstrating competency of surface sampling equipment (e.g. contact plates or swabs) as well as increases in the volume and frequency of surface samples taken.

Surface Sampling Competency - In Section 2.1 of the revised standard - Demonstrating Knowledge and Competency of Core Skills, there is a list of core skills that MUST be demonstrated at least annually by all compounding personnel (See Table 1). In the list, note ‘aseptic technique’ and ‘use of equipment’. In section 6, Microbiological Air and Surface Monitoring, it is stated: “It is important that personnel are trained in the proper operation of the air and surface sampling equipment to ensure accurate and reproducible sampling.” This indicates that competency must be demonstrated by personal annually for the use of surface sampling equipment, such as contact plates and swab sample collection devices. In addition, aseptic technique is an important skill required for proper surface sampling in order to limit the generation of false positives in your pharmacy.

• Hand hygiene

• Garbing

• Cleaning and disinfection

• Calculations, measuring, and mixing

• Aseptic technique

• Achieving and/or maintaining sterility and apyrogenicity

• Use of equipment

• Documentation of the compounding process (e.g., master formulation and compounding records)

• Principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO Class 5 area

• Proper use of primary engineering controls (PECs)

• Principles of movement of materials and personnel within the compounding area

Surface Sampling Quantities and Frequency Increases - In previous versions of this chapter, the recommendation was to perform ‘periodic’ surface sampling, which in many cases, resulted in surface sampling being performed on a limited bases such as during the certification process. In order to raise the bar and improve contamination control in these facilities, the new version of this chapter requires surface sampling to be performed on a monthly basis for Category 1 and 2 CSP’s and on a weekly basis, including at the end of each batch for category 3 CSP’s. The chapter does not call out specific minimum quantities of surfaces samples that must be taken per area of facility; however, ISO 14644-1:2015(E) Table A.1 – ‘Sampling locations related to cleanroom area’, is referenced and compounding pharmacies are required to determine the adequate number of samples to be taken at their facility for the activities that they are performing.

Given the degree of changes to USP 797, it is important for sterile compounding pharmacy management to consider how to manage resources in order to meet the new requirements for environmental sampling. Stratix Labs is here to help and has created a convenient test kit for demonstrating surface sampling competency called the Enverify Surface Sampling Competency Kit.