Vol. 1, Issue 2  ‣ May 2024

Table of Contents

Environmental monitoring (EM) in terms of pharmaceuticals refers to the process of assessing and controlling the environment within manufacturing facilities, particularly cleanrooms, to ensure that they meet cleanliness and safety standards. Even minor environmental contaminants can compromise product quality and safety. Technicians in the Quality Control or Quality Assurance Departments, Pharmacists, or other dedicated pharmacy personnel may 

perform environmental monitoring in their facilities. There are multiple reference standards from which pharmacies and pharmaceutical manufacturers can follow to advise their EM programs, including USP <797>, USP <1116>, ISO 14644 and EU GMP ANNEX 1. Testing frequency depends on the type of facility in which it is being performed, however, the information collected from routine environmental monitoring can be used to determine action limits, to identify trends within unique testing environments, and to guide personnel to employ corrective actions when limits are exceeded.

Regular air quality monitoring is essential to ensure that airborne particles, including microorganisms, are within acceptable limits.

Settling plates are used in passive air sampling as a method to assess potential microbial contamination in cleanrooms. Petri dishes containing a culture medium, such as Tryptic Soy Agar for bacteria and Sabouraud's Dextrose Agar for fungi, are left open in the cleanroom environment. As air circulates in the cleanroom, airborne particles, including microorganisms, settle onto the surface of the agar. This allows for the collection of microbial contaminants that may be present in the air. Once samples are obtained, plates are incubated to promote growth, microorganisms are counted, and results are reported as the number of colony forming units (CFU) per time sampled.

Keep reading to discover how active air sampling, gas sampling, particle counting, surface sampling, and advanced microbial identification techniques like MALDI-TOF are integral to a comprehensive environmental monitoring program, ensuring sterility and safety in pharmaceutical manufacturing.

Discover Reliable Cleanroom Monitoring Solutions

TRIO.BAS™ DUO CABLE Kit, 200 Liters per Minute, Petri Plate, with Charging Cable

Offers efficient air sampling using the impaction method, collecting viable particles from sampled areas onto agar plates.

With a flow rate of 200 liters per minute, this kit includes innovative features such as an ergonomic design, manual or automatic operations, and Bluetooth® capabilities for seamless data transfer to PC.

Compliant with ISO standards and USP guidelines, it ensures reliable and accurate air quality monitoring in controlled environments.

Cost Reduction with In-House Environmental Monitoring: Pharmacies that insource environmental monitoring (EM) programs typically report significant cost reduction compared to outsourcing. This cost-saving measure is beneficial for maintaining compounding and clean room environments while ensuring safety and quality for patients receiving compounded sterile products.

Cross-Functional Collaboration for EM Programs: Implementing a fully-fledged EM program requires cross-functional relationships among various departments such as the laboratory, pharmacy, and infection control. This collaboration ensures that all program components are effectively managed and that personnel are competent in all facets of the program. 

Sterile Irradiated Culture Media Plates for Environmental Monitoring.

More info: https://hardydiagnostics.com/loktight/

See our FREE and complete catalog of Pharmaceutical Microbiology products for more information.

Synopsis: In a mid-stage trial for Duchenne muscular dystrophy (DMD), a rare muscle-wasting disorder, Pfizer's experimental gene therapy resulted in the death of a young patient due to cardiac arrest. The trial, named DAYLIGHT, focuses on boys aged 2 to 3 with DMD, a genetic disorder affecting muscle integrity. Pfizer's gene therapy, called fordadistrogene movaparvovec, was administered to the patient in early 2023. The company, along with an external data monitoring committee, is reviewing the data to determine the cause of the adverse event. Despite the incident, Pfizer remains committed to ongoing trials, including the late-stage CIFFREO study for boys aged 4 to less than 8 with DMD, and expects to begin analyzing results soon. The company has paused dosing in the cross-over portion of the CIFFREO study but continues other trials where dosing has been completed.

Joelle Brackeen

PHARMACEUTICAL PRODUCT MANAGER

 

From air quality to surface sampling and contamination investigations, it's clear that vigilance and adherence to established protocols are paramount in safeguarding patient well-being and ensuring product efficacy. Let's continue to prioritize excellence in environmental monitoring to uphold the highest standards in pharmaceutical manufacturing.

Do you have a suggestion, comment, or question? Please contact Joelle here.

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