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ISO7 Slovenia Removable Wall Auto Repair Modular Clean Room
2025-10-13
AIRKEY recently designed and built a modular sterile compounding pharmacies that complies with USP797 standards for a USA client in pharmaceutical industry.
Project name: USP 797 Compliance Modular Cleanroom - Sterile Compounding Pharmacies
Equipment area: 22㎡
Equipment internal height: 2.5 m
Equipment cleanliness: ISO7 (Class 10,000 Grade C )
Industry: Pharmaceutical
Project country: Georgia, USA
Project features:
1.Modular structure design for quick and efficient construction
No suspended ceiling required, beyond space limitation. Self-supporting aluminum alloy frame with rounded corners for easy cleaning and dust reduction, combined with insulated sandwich panels. All components are prefabricated and pre-assembled in the AIRKEY factory. The intelligent HVAC system,FFU, return air panels, air conditioners and other equipment are integrated into the clean room wall panels, packed and shipped to customers, and can be efficiently modular installed on site within 3-5 days.
2.Three-Zone Independent Control:
Control panel independently adjusts FFUs and lighting per zone. Differential pressure gauges monitor positive pressure to prevent contamination and ensure safety.
3.Logical Zoning to Prevent Contamination：
Has three connected rooms: dirty ante room, clean ante room, and main cleanroom—to ensure proper personnel and material flow, minimizing contamination risks and meeting pharmaceutical standards.
4.Pass Box & Automatic Door for Clean, Efficient Access：
Pass box enables sterile material transfer; automatic sliding door offers space-saving, touch-free access to enhance hygiene and convenience.
5.Viewing Window & Outlets
Tempered glass windows allow easy internal monitoring while maintaining sealing. Custom power outlets meet equipment electricity requirements, enhancing operational convenience.
What is a Sterile Compounding Pharmacies?
A Sterile Compounding Pharmacy is a professional pharmacy that customizes Sterile drugs for patients. In a clean environment that meets the USP797 standard, the drugs are prepared by trained pharmacists or technicians to ensure that the drugs are sterile, free of particles and pyrogenic contamination.
Modular Sterile Compounding Pharmacies is a USP 797 / EU GMP Sterile Compounding Pharmacy constructed by prefabricated modular structure. It is prefabricated in the factory, quickly installed on site, and equipped with cleanroom equipment (such as FFU, laminar flow benches, and air purification systems).
Common sterile medications include:
Injectables (IV solutions, chemotherapy drugs, antibiotics, etc.)
Ophthalmic medications (eye drops, intraocular injections)
Implantable pumps or dialysis fluids
Personalized nutritional solutions (e.g., TPN, total parenteral nutrition)
Why is USP 797 compliance important for sterile compounding pharmacies?
USP 797 ensures a sterile compounding environment in pharmacies:
Cleanrooms that meet USP 797 specifications and reach ISO Class 7 meet the stringent requirements for sterile drug production and maintain a high-standard clean environment.
1. Ensuring Patient Safety
USP797 regulates the sterile drug compounding environment, personnel practices, and quality control. Failure to adhere to these regulations can lead to drug contamination with microorganisms, endotoxins, or particulate matter, posing a direct threat to patient life. Historically, the United States has experienced a cluster of fungal meningitis cases resulting from improper compounding, resulting in dozens of deaths. Strictly adhering to USP797 not only complies with regulations and demonstrates pharmacy professionalism and responsibility, but also protects pharmacies from potentially costly compensation and lawsuits due to patient infection or death and enhances patient trust.
2. Complying with Regulatory Requirements
USP 797 is a mandatory standard adopted by state boards of pharmacy, the FDA, and the Joint Commission. Non-compliance can result in suspension of operations, penalties, and even license revocation.
3. Improve drug quality and consistency
Ensure consistent drug quality and avoid batch-to-batch variations by standardizing cleanroom levels, airflow management, and personnel training.
What ISO classifications are required to comply with USP797?
Comparison Table (USP <797> vs. ISO 14644-1)
| Area | USP <797> Classification | ISO Class (At Rest / In Operation) |
|
Primary Engineering Control (LAFW, BSC, CAI, CACI) |
Critical Area | ISO 5 |
|
Buffer Area (Cleanroom supporting PEC) |
Buffer Area | ISO 7 |
|
Ante Room (Support/Preparation Area) |
Ante Area | ISO 7–8 |
