We are seeking proposals from qualified suppliers for the design, supply, and installation of a Pharmaceutical Clean Room that meets USA standards for compounding pharmacies. This clean room will be used for the preparation of sterile medications and other customized pharmaceuticals. The facility must comply with all relevant USP <797>, USP <800>, FDA, OSHA, and other regulatory standards. Our goal is to create a controlled, sterile, and safe environment for pharmaceutical compounding operations.

Key Requirements:

Compliance with USP <797> and USP <800> Guidelines:

The clean room must meet the latest USP <797> standards for sterile compounding and USP <800> standards for handling hazardous drugs.
Compliance with FDA and OSHA regulations is essential to ensure the safety of both the products and the staff involved in the compounding process.
Air Quality Standards (Class 10, 000 to Class 100):

The clean room must be designed to meet air cleanliness levels from Class 10, 000 to Class 100 as per industry standards, with HEPA filtration systems to ensure minimal airborne particulate matter.
The filtration system should be capable of removing 99.97% of airborne particles 0.3 microns and larger.
Advanced Airflow and Ventilation Systems:

The clean room must include a positive pressure airflow system that maintains higher air pressure within the room than in surrounding areas, preventing contamination.
Laminar Flow Hoods and Biological Safety Cabinets (BSCs) should be included to direct filtered air over compounding work surfaces.
The HVAC system should include integrated temperature and humidity control mechanisms to maintain optimal conditions for both compounding and storage.
Modular and Flexible Design:

The clean room should be constructed with modular panels to allow for future flexibility in reconfiguration, expansion, or modification as our needs evolve.
Easy-to-clean, smooth, and seamless surfaces are required to facilitate regular cleaning and minimize the risk of contamination.
High-Performance Flooring:

The clean room must be equipped with slip-resistant, smooth, non-porous flooring that is resistant to chemicals and is easy to clean and disinfect.
Controlled Entry and Exit Protocols:

The clean room design should incorporate airlocks and pass-through chambers to prevent contamination during the entry and exit of materials and personnel.
Strict gowning and de-gowning areas should be included to ensure that all personnel comply with hygiene and safety protocols before entering or exiting the room.
Contamination Prevention Systems:

The clean room must feature antistatic coatings, airtight seals, and hygienic materials throughout to prevent cross-contamination.
UV sterilization lamps should be integrated to reduce microbial contamination.

Integrated Monitoring and Control Systems:

The clean room must be equipped with environmental monitoring systems to track and log temperature, humidity, particulate levels, and air pressure.
The system should include automatic alerts and detailed data logging for regulatory compliance and quality assurance.
Ergonomic and Safe Workspaces:

Work surfaces, including laminar flow hoods, should be ergonomically designed and made from non-porous, easy-to-clean materials.
Adequate lighting is required to provide clear visibility during compounding, reducing eye strain and ensuring safety.
Certification and Documentation:

The clean room must include full documentation, including certification that the system meets USP <797>, USP <800>, FDA, OSHA, and other relevant regulatory standards.
Calibration and validation reports for air pressure, temperature, and airflow performance are required as part of the installation process.

The clean room must have a floor size of 120 feet by 120 feet, with a max ceiling height of 8 feet.