Learn More: USP <797> Design Principles

Terra manufactures USP-compliant cleanrooms that meet requirements for sterile drug compounding (USP-797) and both sterile and non-sterile hazardous-drug compounding (USP-800). Turnkey rooms are designed for efficient ordering and operation; contact a Terra Product Specialist for custom floorplans.

Hardwall pharmacy compounding rooms feature HEPA-filtered ante-chambers and buffer rooms made of polypropylene, a durable material that resists damage from sterilizing agents such as IPA. BioSafe® hardwall rooms are manufactured using double-wall, insulated stainless steel, featuring radius corners to simplify cleaning and reduce sites that may harbor contaminates.

503A Traditional Compounding Pharmacies and 503B Outsourcing Facilities: Optimize Your Compounding Cleanroom for FDA Inspections

As a result of the 2013 Drug Quality and Security Act (DQSA), all traditional compounding pharmacies and outsourcing facilities are subject to FDA oversight. Since enactment, the FDA has taken aggressive steps to strengthen enforcement and implement stricter standards for sterile compounding. Any “insanitary conditions” are in direct violation of Sections 501(a)(1) and (a)(2)(A) of the FD&C Act (Title 21 CFR), which gives the FDA inspectors broad discretion for determining what constitutes sterile conditions.

Because adverse events and sterility test failures are a surefire way to attract the undivided attention of the FDA and State Board of Pharmacy, experts in the field of pharmaceutical compounding strongly recommend using an ISO 5 cleanroom to substantially lower the bioburden of the cleanroom environment and restrict the number of colony-forming units (CFUs) introduced into the critical areas.

Specify the following for compliance with cGMP requirements:

• 1 additional FFU in the Buffer Room
• 1 additional FFU in the Ante-Room
• Tier II Environmental Control System

Please contact us to add these options to your compounding cleanroom.

Clean Rooms Optimized For Outsourcing Facilities (Section 503B)

The FDA enforces standards for outsourcing facilities referred to as Current Good Manufacturing Practices (CGMPs), which are a strict set of quality assurance requirements intended to prevent potentially deadly contamination of CSPs. All 503B compounding pharmacies must comply with CGMP standards (21 CFR Parts 210 and 211) and will be inspected by the FDA upon registration. In addition to satisfying quality assurance requirements, the FDA also expects all pharmaceutical compounders to comply with national industry standards (i.e. USP 797 and 800). Outsourcing facilities must also comply with any applicable state regulations, including licensing requirements.

In order to best ensure compliance with CGMP standards, experts in the field of pharmaceutical compounding strongly recommend using an ISO 5 cleanroom to substantially lower the bioburden of the cleanroom environment and restrict the number of colony-forming units (CFUs) introduced into the critical areas. A "cleaner" compounding cleanroom will help prevent sterility test failures (e.g. viable air sampling and fingertip sampling) and avoid additional scrutiny from the FDA and State Boards of Pharmacy.

Terra's designs reflect these recommendations for non-sterile-to-sterile (high-risk) compounding and for outsourced compounding operations.

Compliance Notice

These BioSafe® compounding cleanrooms are designed to the requirements of USP 797 as published in USP 40-NF 35. However, because practice standards vary from state to state and depend on compounding operations, Terra recommends consultation with our compounding experts to evaluate suitable for your application.