Developing a Sampling Program for Monthly Environmental Monitoring

Ally Fiscus ·

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. 

  1. 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.

  2. 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.

  3. 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>.

  4. 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.

  5. 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!

 

Common Bacteria Found In Your Cleanrooms

Ally Fiscus ·

Bacteria are identified at LAB 797 using MALDI-TOF MS, a method of mass spectrometry. This allows us to quickly identify any potential contaminants on environmental samples from your facility. It is highly recommended that your pharmacy take action according to your SOP (Standard Operating Procedure) upon receiving such results.

Below are some common contaminants isolated from cleanroom facilities:

  • Bacillus sp.

    • Closely related to: Priestia sp., Paenibacillus sp., Metabacillus sp., Niallia sp.

    • Common isolates: Bacillus subtilis, Bacillus cereus, Bacillus halosaccharovorans, Priestia megaterium, Paenibacillus polymyxa, Niallia circulans

    • Widespread in most environments, commonly seen in rooms such as Segregated Compound Areas (SCA) and Ante Rooms

    • Occasionally found on fingertip plates or after compounding

    • Can appear as many different colors and textures on agar plate, usually spreading across all of the agar

  • Staphylococcus sp.

    • Common isolates: Staphylococcus epidermidis, Staphylococcus hominis, Staphylococcus haemolyticus, Staphylococcus aureus

    • Often found in various rooms throughout the cleanroom or in the environment

    • Commonly found on fingertip samples

    • Staphylococcus sp. are usually human contaminants, found naturally on skin and spread through surfaces

    • Can appear sticky or creamy on agar plate, usually white or light yellow in color

    • Staphylococcus aureus is known to cause severe infections in immunocompromised patients

  • Micrococcus sp.

    • Common isolates: Micrococcus luteus, Micrococcus flavus

    • Often found in various rooms throughout the cleanroom or in the environment

    • Micrococcus sp. are common human and environmental contaminants found in soil, water, air, and human skin

    • Can appear as raised and creamy on agar plate, and usually yellow in color

USP 797 Compliance - Current Regulations and Guidelines

Ally Fiscus ·

As of November 1, 2023, full compliance to the revised USP 797 is expected. Below is a quick guide to the changes, and LAB 797 is here to help you and your pharmacy navigate.

  • Media Fill and Personnel Testing: Personnel compounding Category 1 and 2 CSPs must test initially and every 6 months. Personnel compounding Category 3 CSPs must test initially and every 3 months.

  • Dual Incubation: Dual incubation, or the use of general-use media in both low and high incubation temperatures, is now an acceptable method for recovering both bacterial and fungal contaminants. This is a great, cost-effective option for pharmacies! Dual Incubation is also required for personnel samples.

  • ISO Class Action Limits: Air Sampling limits remain the same as previously. Surface Sampling limits have changed. See https://www.lab797.com/faqs for details on the current action limits.

  • Increased Surface Sampling: Monthly surface sampling throughout all ISO-classified areas is now recommended for most pharmacies. This can be done internally

  • No Pathogenic Species: Pathogenic species, such as molds, yeasts, and Gram-negative rods, are no longer action items.

  • Certification: Done externally every 6 months.

Reminders

  • USP 800 is enforceable as of November 1, 2023

  • USP 797 is enforceable November 1, 2023

Let LAB 797 help you navigate through these changes in USP 797. We can create custom environmental and personnel sampling solutions for your pharmacy to make compliance easy. Custom solutions include recurring shipping of surface/personnel plates, custom media-fill testing kits, and quick identification and results.