Pharmaceutical Cleanroom Certification Services

GL Technologies prides itself in providing microbiological contamination testing and deliverables to provide essential patient safety in drug development processes.  The team at GL Technologies has a wide array of experience in developing cleanroom contamination controls and environmental monitoring programs for organizations both large and small.  When biotech and pharmaceutical companies are in need of controlled environments, GL Technologies is called in for testing services designed to control microbiological contaminants during critical testing environments.  This also includes the quality of small molecular drugs.  

Environmental monitoring, referred to as "EM" porgrams can assess personnel-growing performances and aseptic behaviors.  A very important part is the testing and maintaining the efficacy of cleaning and disinfectant procedures.  GL Technologies offers a suite of cleanroom certification services to help your organiztion validate cleanroom procedures properly.

Cleanroom & Controlled Environment Monitoring

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

Pharmaceutical and biotech companies must comply with sanitizing guidelines that are detailed within <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>

It is critical to demonstrate compliance to this regulatory guidance by providing daily cleaning, sanitizing floors and counters, and providing cleanable work surfaces for storage shelving, walls, etc.  These procedures need to be implemented so that they are sanitized on a 30 day basis.  Further, ISO Class 5 PEC facilities must be minimally cleaned beginning with the shift, before every batch, and 30 minutes when compounding spills if contamination is the suspected issue.  

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.

GL Technologies provides cleanroom certification services to regions throughout California including San Diego, Los Angeles, and San Francisco helping biopharmaceuticals maintain the highest industry standards for their testing procedures.