Implementing a Robust Viable EM Program

A well-developed viable environmental monitoring (EM) program is essential to the success of those producing sterile drug products and those compounding sterile preparations. Those working in the aseptic manufacturing industry are more likely to have a well established and heavily audited EM program in place. Those in 503A sterile compounding pharmacies and in 503B outsourcing facilities may be at different levels of program development and compliance. To help ensure the implementation of a robust EM program, those responsible for the program must be aware of the challenges and limitations of EM, understand the regulatory landscape, and honestly evaluate the program for compliance. This blog will dive a little deeper into these topics.

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Although EM program requirements will vary from industry to industry, the same basic components apply. Evaluate the EM program against applicable regulatory documents and internal SOPs. Managing EM data can be overwhelming, so look for software that meets internal and regulatory requirements. If managing an EM program is new for you, get help! There many industry experts that can provide the assistance you need to be compliant.

Industry dictates the EM program. There is some overlap in the regulations and standards that apply. Aseptic manufacturing and 503A sterile compounders are the extremes, while the 503B outsourcing facilities fall in the middle.

• Manufacturing
• • CFR/CGMP
  • Annex 1
  • FDA Guidance
  • USP
• 503B Outsourcing Facility
  • CFR/CGMP
  • State law
  • FDA Guidance
  • USP
• 503A Sterile Compounding Pharmacy
  • CFR
  • State law
  • FDA Guidance
  • USP, specifically <797>

When it comes to the EM Program, there are differences between industries and what may be required, but program basics are universal! The program should include but not be limited to following areas.

Training – When developing a training program, be sure it includes sample collection, aseptic technique, and data integrity.

Sample selection – When choosing sample locations, focus on risk to the final product or preparation. There are some USP <797> requirements that sterile compounding pharmacies must follow, such sampling each ISO classified area and collecting a surface sampling in the pass-through.

Media – Media makes or breaks the program. Choose media that comes irradiated and triple bagged. Be sure to store it according to the manufacturer’s requirements. Qualifying multiple media vendors is also recommended, as backorders are inevitable.

Viable sampler – When choosing a viable air sampler, be sure it is industry appropriate. Not all air samplers are created equal and you get what you pay for. Be sure to evaluate the sampler’s flow rate, the d50 cut-off point, if it negatively disrupts airflow, calibration and maintenance requirements, and physical aspects (can it withstand a fall off a cart).

Incubation – Manufacturers and 503B outsourcing facilities must be able to defend their incubation parameters. For sterile compounding pharmacies, the incubation parameters are dictated by USP <797>.

Frequency – Frequency depends on industry. USP <1116> provides valuable guidance on sampling frequencies, based on ISO Class and activities performed in the area. USP <797> also defines the minimum sampling frequencies.

Data management – When it comes to data collection, documentation and trending, there’s no one-size-fits-all answer. However, data integrity and accessibility are key. Utilizing an electronic system can ease some of the regulatory challenges, especially for those collecting many samples.