Pharmaceutical manufacturing facilities operate under Good Manufacturing Practice (GMP) regulations that classify every space by cleanliness level. Adding a kitchen to such a facility requires rigorous engineering controls to ensure cooking emissions do not compromise adjacent cleanroom classifications. Souniny ESP with HEPA polish has been deployed in multiple pharma facilities to bridge this gap.
| Parameter | Specification |
|---|---|
| Model | Heavy-duty Series / Heavy-duty Series with HEPA Polish |
| Airflow | 4,000-6,000 m³/h |
| Filtration Stages | Pre-filter → ESP → HEPA H13 → Carbon |
| HEPA Efficiency | ≥99.97% at 0.3μm (H13 grade) |
| Pressure Cascade | Kitchen negative to corridor, corridor positive to cleanroom |
| Validation | IQ/OQ/PQ documentation package for GMP audits |
| Monitoring | Continuous particle counting with alarm thresholds |
Application Scenarios
- Vaccine manufacturing facility (India): A WHO-prequalified vaccine plant with 1,500 staff installed an Heavy-duty Series with HEPA H13 post-filtration in the staff canteen. The canteen is in the same building as ISO Class 8 cleanrooms. The facility’s quality assurance team required full IQ/OQ/PQ validation of the kitchen ventilation as part of the site’s GMP documentation. The system passed all validation protocols and has operated for 3 years with zero cleanroom air quality deviations attributable to kitchen operations.
- Sterile injectables plant (Germany): A facility manufacturing sterile injectable drugs in ISO Class 5 (Grade A) cleanrooms installed a highly specified kitchen ventilation system. Because the kitchen shares air handling with the office/admin building that is physically connected to the production building, the risk assessment required “no detectable contribution” from kitchen emissions to cleanroom viable particle counts. The ESP + HEPA configuration was validated through environmental monitoring data over 12 months.
- Contract manufacturing organization (Switzerland): A CMO facility producing both small-molecule and biologic drugs operates a 24/7 cafeteria for shift workers. The Heavy-duty Series system was specified with a redundant fan array (N+1) so that no single fan failure could compromise kitchen containment. The redundancy was a specific requirement from the client’s quality audit of the facility.
- API manufacturing plant canteen (China): A facility producing active pharmaceutical ingredients has a canteen in a separate building from production, but the prevailing wind direction can carry emissions toward the production building’s HVAC intakes. The Souniny system with full odor treatment was specified to eliminate any detectable odor at the property boundary — a proactive measure to prevent potential FDA observations during cGMP inspections.
