Services

Cleaning and Disinfection of cGMP Cleanrooms

Pharmaceutical Cleaning and Disinfection Services

Maintaining a sterile environment is critical for the production and packaging of pharmaceutical products. At Prime Cleanroom Solutions, we are committed to delivering industry-leading cleaning and Disinfection solutions tailored to meet stringent regulatory requirements, ensuring product safety and efficacy. Our expertise encompasses key practices, principles, and activities essential for maintaining a contamination-free pharmaceutical environment.

Selection of Cleaning Agents

Effective cleaning eliminates contaminants that can compromise product quality. Our process targets:

Microbial Contaminants:

Bacteria, fungi, and viruses.

Chemical Residues:

From the manufacturing process or previous production batches.

Nonviable Particulates:

Dust, product residues, or other particulate matter.

We collaborate with clients to select the most effective cleaning agents based on their unique manufacturing requirements and facility design.

Selection of Disinfection Agents

Disinfection is essential for controlling microbial risks. We provide guidance on the selection of appropriate agents, including:

Detergents and Cleaners:

Validated agents for removing organic and inorganic residues, compatible with cleanroom surfaces.

Disinfectants:

Recommendations are based on environmental monitoring data, targeting bacteria (spore and non-spore formers), viruses, protozoa, and fungi. Options include alcohol, chlorine compounds, hydrogen peroxide, and quaternary ammonium compounds.

Sterilants:

For addressing gross contamination, we suggest sterilants such as ethylene oxide, vaporized hydrogen peroxide, or peracetic acid.

Customized Cleaning and Disinfection Procedures

Our team develops cleaning and Disinfection protocols tailored to client-specific requirements, based on air, material, personnel, and equipment flow. Services include:

Post-Construction Cleaning:

Removal of contamination and residues after facility turnover, using HEPA vacuuming, appropriate detergents, and mechanical action.

In Situ Cleaning Validation:

Development and validation of cleaning protocols based on viable and non-viable sampling maps and facility design. Steps include pre-cleaning sampling, cleaning and post-cleaning sampling.

Routine Cleaning and Disinfection:

Creation and implementation of routine schedules, including rotation of cleaning agents and disinfectants to ensure sustained efficacy.

Environmental Monitoring Integration:

Adjustments to cleaning procedures based on ongoing environmental monitoring data.

Regulatory Compliance and Support

Pharmaceutical cleaning and Disinfection must comply with cGMP regulations, USP standards, and PDA recommendations. Our services ensure full alignment with these requirements:

Good Documentation Practices (GDP):

All clean room documentation are attributable, legible, contemporaneous, original, and accurate (ALCOA).

Training:

Our technicians and managers are equipped with up-to-date knowledge on cleaning and Disinfection techniques, emphasizing contamination control.

Audit and Inspection Readiness:

Field managers conduct post-cleaning inspections to verify adherence to protocols and prepare facilities for audits.

Contamination Investigation Support:

Expert assistance in addressing contamination incidents, including root cause analysis and corrective actions.