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.

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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.

Why Cleanrooms are Vital in Pharmaceuticals

Cleanrooms are specialized environments designed to minimize airborne particles, microorganisms, and other contaminants. In pharmaceutical settings, these controlled spaces are where processes like drug manufacturing, packaging, and testing occur. Even a tiny particle or microbial contamination can compromise the integrity of medications which risks patient safety.

Cleanroom 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 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

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.

Cleanroom Popular Articles

Meeting Regulatory Requirements: Pharmaceutical Cleanroom Certification

In the world of pharmaceuticals, maintaining the safety, potency, and quality of medications is of the utmost importance. This assurance begins at the heart of drug production facilities: the cleanroom. These specialized environments play an important role in maintaining sterile conditions necessary for pharmaceutical manufacturing. To meet strict regulatory requirements and industry standards, cleanrooms must undergo rigorous certification processes. Understanding the essentials of pharmaceutical cleanroom certification is imperative for pharmaceutical companies to uphold the highest standards of safety and quality.

The Role of Cleanroom Certification in Biopharma: An Overview

For biopharmaceutical companies, maintaining the highest standards of cleanliness and sterility is non-negotiable. The manufacturing processes involved in producing pharmaceuticals, especially in biopharma, demand perfect conditions to guarantee product quality, safety, and potency. One aspect that plays an important role in maintaining these standards is cleanroom certification. Let's dive into the significance of cleanroom certification within the biopharmaceutical industry, outlining its role and implications.

Why Cleanroom Certification?

Regulatory Compliance

Certification verifies adherence to strict regulatory guidelines such as those set by the FDA (Food and Drug Administration), EMA (European Medicines Agency), and other regulatory bodies. Compliance with these standards is non-negotiable, and certification validates that the cleanrooms meet or exceed these requirements.

Quality Assurance

Certification guarantees that the cleanroom facilities consistently maintain the specified cleanliness levels necessary for pharmaceutical operations. It involves rigorous testing of air quality, particle counts, pressure differentials, and microbial levels, making sure that the environment remains conducive to safe and sterile production.

Risk Mitigation

Certified cleanrooms significantly reduce the risk of product contamination. By undergoing regular certification processes, pharmaceutical companies can identify and fix any potential issues or deviations that might compromise the cleanliness standards, which minimizes the risks associated with compromised product quality.

Consumer Safety

The certification of pharmaceutical cleanrooms directly contributes to maintaining the safety of consumers. By upholding strict cleanliness standards, certified cleanrooms minimize the possibility of producing medications that could cause harm due to contamination, making sure that patients receive safe and effective products.

About GL Technologies

As a full-service company specializing in equipment calibration, repair, and certification services for biopharmaceutical, pharmaceutical, and medical device industries. Our team has extensive experience working with sPRT calibrations along with CMMS software, HPLC OQ validation, and fume hood certifications. Companies of all sizes rely on our team to implement, maintain, and keep their research and manufacturing processes compliant with regulatory standards. Other specialties include building maintenance systems, and mass spectrometry calibrations.