USP 800 Pharmaceutical Cleanroom System

USP 800 Pharmaceutical Cleanroom System

USP 800 Pharmaceutical Sterile/Non-Sterile HD System

Application: ISO-7 Cleanroom (positive and negative pressure rooms)

Size: 16’ x 71’ x 8’ high with internal Gown Room

Requirements and details:

Pharmaceutical Cleanroom Purpose and Applications

The purpose of this pharmaceutical cleanroom system was to provide a critical FDA Compliant multiuse environment allowing manufacturing of GLP-1s, Peptides, powders and compounding. USP 800 establishes enforceable standards for the safe handling of hazardous drugs (HDs) to protect healthcare workers, patients, and the environment.

Automated Doors and Personnel Safety

Due to strict guidelines set forth by the FDA, “touch free” automated sliding doors were included in each room. A wave plate allows entry/exit and also includes a break away feature in the event of an emergency or power outage to ensure personnel can exit quickly and safely.

Durable and Cleanable Wall Finishes

To ensure durability and cleanliness, smooth FRP wall finishes were provided. This material will not break down with cleaning agents and will not shed. All connections were sealed using cleanroom grade sealant specific to this type of critical environment.

Pass-Through Chambers for Material Transfer

Custom 304 Stainless Steel wall mount pass through chambers were included between rooms providing optimal efficiency for staff. In addition, HEPA filtered wall mount pass through chambers were included. This allows staff to pass sample -materials to non-classified areas without contamination by providing clean positive pressured air and interlocking doors.

Mechanical Systems and Pressure Cascading

Two High-Performance DOAS (dedicated outside air systems) packaged units were integrated with an exhaust fan (for negative pressure areas) to ensure specific mechanical design cascading was achieved.

Automated Controls, HEPA Filtration and Validation

To ensure all HEPA units perform at optimal requirements an ACS (automated control system) was included so staff can easily be notified on room performance while also including night time set-back for energy efficiency while system is not in use. Room side replaceable (RSR) filter packs were provided to ensure ease of exchange without disturbing the environment for certification and validation purposes. Specific air balancing and test validation/certification was provided as well.

Cleanroom Flooring and Fire Protection

Sheet vinyl flooring was provided throughout with radius coving for ease of cleaning.

Fire sprinklers were dropped into the new cleanroom with flush heads to ensure a positive seal and meet NFPA requirements

Custom Pharmaceutical Cleanroom Solutions

If you have HD sterile/non-sterile pharmaceutical application please reach out to one of our critical environment specialists to see how we can prove a custom solution to fit your exact needs!