Cleanroom Manufacturing — The Environment Behind Every Vial
The environment in which a pharmaceutical product is manufactured is just as important as the ingredients themselves. A single airborne particle or microbial contaminant introduced during filling can compromise an entire batch. Our ISO 5/7-aligned cleanroom is designed specifically to prevent contamination at every stage of the filling process.
ISO Cleanroom Classification
Cleanrooms are classified by ISO particle count standards. ISO Class 5 (also known as Class 100) allows no more than 3,520 particles ≥0.5 microns per cubic meter of air — the standard for the critical zone directly around the filling point of sterile pharmaceutical products. Our facility maintains the environmental controls required for pharmaceutical-grade sterile manufacturing.
HEPA Filtration and Positive Pressure
Our cleanroom uses HEPA (High-Efficiency Particulate Air) filtration, which removes 99.97% of particles ≥0.3 microns. Positive air pressure inside the cleanroom relative to adjacent areas ensures that any air leakage flows outward rather than inward — keeping external contaminants from entering the critical environment.
Environmental Monitoring Program
We continuously monitor our cleanroom environment for: airborne particle counts, temperature and humidity, pressure differentials, and surface microbial contamination (via settle plates and contact plates). Monitoring data is reviewed regularly and any excursion triggers corrective investigation.
Personnel Gowning and Aseptic Technique
All personnel entering the filling area follow a documented gowning procedure: sterile gloves, gown, mask, and hair/beard covers. Aseptic technique training is required for all production staff. These controls are the last line of defense against the most common source of sterile product contamination — human contact.
How This Relates to Your Order
When you order from Renew Lab Group, every one of these quality steps has already been completed on your lot before it ships. Your Certificate of Analysis documents the specific results — not generic “complies” statements, but actual measured values from the batch you receive.
Quality You Can Verify. Documentation You Can Trust.
HPLC-tested. Endotoxin-controlled. COA included with every order.
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