USP is addressing critical industry needs by helping ensure product safety with advanced microbiology solutions.
Creators of pharmaceutical products, including drug developers, manufacturers, and compounders, strive to accelerate patient access to the quality medicines they need. Tight timelines and resource constraints drive efforts to optimize operational efficiencies, including robust quality control strategies. Reliable microbiological quality control solutions are essential to help reduce contamination risk, support quality, and safeguard patient safety.
USP has been a trusted source of solutions to microbiology challenges for the pharmaceutical industry since establishing the first microbiological documentary standard in 1965, helping companies confidently navigate regulatory expectations for contamination control.
Building upon this long history, USP now offers tools to enhance microbial contamination control in manufacturing and compounding, based on innovative preservation technology.
These tools, combined with USP quality standards, can improve contamination control and sterility assurance, helping ensure drug safety and boosting manufacturers’ confidence in their ability to meet regulatory expectations.
Enverify™ Viable Surface Sampling Competency Kit
Microbial-coated test surfaces for evaluating surface sampling competency
Help evaluate the competency of your sampling personnel
Qualification of personnel who collect surface samples is a regulatory requirement and a crucial activity for an effective environmental monitoring program. Sampling method performance, including recovery efficiency, consistency, and aseptic technique, drives the quality of data that is generated and significantly impacts the integrity of an environmental monitoring program.
Enverify™, the First Standardized Tool for Evaluating Surface Sampling Competency
- The Enverify™ Viable Surface Sampling Competency Kit is the first standardized tool that enables you to evaluate and document surface sampling competency with quantitative data.
- Each Enverify™ test surface contains a precise quantity of microorganisms, providing a benchmark for you to evaluate, verify, and compare performance.
- Blinded blanks are included to evaluate the competency of reporting negative results.
- After the end-user completes sampling, recovery results are reported to USP for evaluation. Each submission receives an individual performance report; qualifying personnel will also receive a Certificate of Performance.
Help achieve compliance with pharmaceutical and compound pharmacy industry standards, guidelines and regulations
USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations
- Section 2.0 – “All personnel who compound or have direct oversight of compounding personnel must be initially trained and qualified by demonstrating knowledge and competency… initially and at least every 12 months in appropriate sterile compounding principles and practices…”
- Section 6.1 – “It is important that personnel are trained and competent in air and surface sampling procedures to ensure accurate and reproducible sampling.”
- Section 20 – “All facilities where CSPs are prepared must have and maintain written or electronic documentation to demonstrate compliance with the requirements in this chapter. This documentation must include, but is not limited to, the following: Personnel training, competency assessments, and qualification records including corrective actions for any failures…”
Help reduce your process risk using Enverify™
Enverify™ can be used in training and evaluation programs for personnel to demonstrate knowledge and competency in surface sampling as part of the environmental monitoring and aseptic technique evaluations.
Benefits for Surface Sampling Programs
- Demonstrate recovery efficiency and aseptic technique
- Document personnel competency
- Validate compliance with regulatory guidelines & best practices
- Identify training opportunities & improve sampling consistency
