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Pharmaceutical Cleanroom Certification Services

Controlling microbiological contamination in drugs bio and pharmaceutical studies and deliverables is essential to patient safety. GL Technologies has the crucial experience in developing cleanroom contamination controls and environmental monitoring programs, in the biotech and pharmaceutical industries in need of controlled environments. Our cleanroom testing services are designed to control microbiological contaminants in critical testing environments as well as the quality of small molecule drugs.

EM (environmental monitoring) programs assess personnel-gowning performances and aseptic behaviors, but also include a microbiological environment program. Another important part is testing and maintaining the efficacy of cleaning and disinfection procedures. We offer a suite of services of cleanroom certification procedures to verify validated cleaning procedures have been implemented properly.

Cleanroom certification and controlled environment monitoring services:

Surface, viable air, total particulate air (non-viable) sampling
Compressed gas contaminant testing
Compressed air line sampling
Passive/setting plates
Autoclave validations to FFDCA Sections 503A or 503B for compounding pharmacies
Primary Engineering Control (PEC) (laminar flow hoods, isolators, and Class I, II, III biological safety cabinets)
Growth promoted media
Calibrated equipment
Incubation and enumeration
Microbial identification
Electronic reporting
Customized environmental monitoring SOP generation

Cleanroom Validation and Facility Validation Support

Environmental monitoring performance qualification (EMPQ) and environmental monitoring operational qualification (EMOQ/EMPQ/OQ/PQ)
Disinfectant and cleaning studies
Water system qualifications
Risk assessment
Summary report

Environmental Monitoring of Sterile Compounding Areas

Pharmacies must comply with sanitizing guidelines detailed within USP <USP 797> for compounded sterile preparations. It is important to know that when handling hazardous drugs and materials in healthcare settings, the procedures must be detailed within USP <800>

The reason for this is that it is critical to demonstrate compliance to this regulatory guidance: daily cleaning, sanitizing counters, and having cleanable work surfaces for ceilings, walls, and storage shelving. They must be sanitized on a monthly basis. Furthermore, ISO Class 5 PEC sites must be minimally cleaned at the beginning of each shift, before each batch, every 30 minutes when compounding, after spills, and when contamination is known or suspected.

To learn about our customized approach to controlling microbial contaminants in biopharmaceutical manufacturing facilities, compounding pharmacies, hospitals, and more, or to speak with one of our experts, contact us today.