Pharmaceuticals Manufacturing Facilities
Clean Environment is of outmost importance in any Pharmaceutical industry as the Environment needs to be free of external contaminants and infections. In Pharmaceutical industry where potentially harmful Drugs are being manufactured, The Personnel and the surrounding Environment need to be protected as well. HVAC System & Construction of Clean Room plays a very important part in maintaining the integrity of such Clean Rooms.
CLEMENT ENGINEERS take care during designing and installation of Clean Room Construction & HVAC system implementation to minimize the introduction, generation and retention of particles inside the room with distribution of proper lamination, and in which the relevant parameters, e.g. temperature, humidity and pressure, are controlled as advised in Good Manufacturing Process (GMP) guideline of regulating Authorities.
We evolve all appropriate methodologies, systems and procedures related to HVAC system & required related Validation documentation to honor the requirements as per above guideline.
Moreover, as the required conditions are product specific and process specific, we can design the system as per USERS REQUIREMENT SPECIFICATION (URS).
BASIC CLEANROOM HVAC DESIGN CONSIDERATIONS
- Prevention of ingress of external contaminant particles.
- Dilution & scavenging of contaminant particles generated by process / personnel.
- Containment of hazardous / harmful agents.
- Prevent product to product cross-contamination.
- Protection and optimum comfort of personnel.
- Meet special requirements for products (like Low Relative Humidity).
STRATEGIES FOR PARTICULATE CONTAMINANT CONTROL
The challenge in designing a CLEAN ROOM HVAC system is to remove the particles generated / retained in the system and ingress / egress of particles to and from the system. Some strategies taken cared by us has been furnished hereunder –
- Trap the Contaminants in the Filtered Clean air stream
- Transport them to the Filtration System
- Remove the particles from the air stream by filtration through series of Filters including High Efficiency Particulate Air (HEPA) Filters.
- Ensure that air is introduced in the clean-room with minimal contaminant particles.
- Control Temperature and RH parameters to control biological growth
- Maintain suitable Pressure Gradient to minimize ingress / egress of particulate matter.
Pressure Gradients between adjoining areas is utmost critical in Pharmaceutical manufacturing process to prevent ingress of external contaminants and escape of generated particles. Creation of required pressure regime requires additional fresh air to pressurize positive pressure rooms and to compensate for exhaust in negative pressure rooms.
SPECIAL CONSIDERATIONS FOR INSTALLATION OF CLEAN ROOM HVAC SYSTEM
- Taking Special care during fabrication of Duct suitable for high pressure system, Application of sealing compound to reduce leakage and ensuring leakage limit by leak testing of Duct with suitable method. Limiting toxic paints and plain mild steel for ducting process.
- Installation of HEPA Filter inside a suitable housing having provision of control of Air Volume and Integrity Test wherever required.
- Installation of Return Air Riser with air volume control measures and filters at lower level of manufacturing area ensuring easy removal of dust particles.
- Installation of Capsule perforated Air End Terminals ensuring unidirectional air flow.
CLEAN ROOM VALIDATION TESTS MANAGABLE BY US
- Air Flow Velocity and Uniformity Tests
- HEPA Filter Installation Integrity Test
- Air Flow Pattern Test
- Airborne Particle Count Test
- Room Pressurization Test
- Temperature Humidity Test