Compounding Cleanroom for IV Solutions and Chemotherapy (USP 797 and 800)

• Industry: Compounding Pharmacy
• Square footage: 310 square feet (divided in 3 rooms)
• Cleanroom Class: USP 797 & USP 800
• Layout: ISO 7 Buffer and Chemo rooms + ISO 7 Anteroom
• Location: Maine, USA

Hazardous and Sterile Compounded Medications Clean Rooms for IV Solutions and Chemotherapy

Maine is known for offering high-quality hospital care and this client is no different. This hospital offers various healthcare treatments that benefit the rural population and many tourists on a yearly basis. When a cancer diagnosis is given, the area patients needed to travel far from home to receive cancer treatments. The same problem occurred for blood disorders and many other diseases that require transfusions.  To resolve this, our client decided to offer oncology services to their long list of treatments. They needed USP 797 and USP 800 cleanrooms for the compounding of hazardous drugs and sterile preparation for high-quality cancer care. The 310 ft² clean room area is divided into 3 rooms: an ISO 7 anteroom and ISO 7 IV solutions cleanroom and chemo room.

IV Solutions and Sterile Compounding in USP 797 Cleanroom

Intravenous medications contain a high level of glucose, which makes them prone to bacterial contamination, which would be disastrous for the health of the patients being treated. To eliminate the risk of contamination, IV solutions need to be compounded in a sterile clean room environment, under the USP 797 guidelines for sterile compounding. An ISO 5 laminar airflow hood is also required for the preparation of IV solutions and IV bags.

USP 800 Regulations for Chemo Rooms / Infusion Areas in Cancer Treatment

In-hospital chemotherapy services usually require two separate rooms to provide the treatments: the chemo room, where the hazardous drugs are compounded, and the infusion area, where patients receive cancer medication. To be compliant, the chemo room needs to respect the USP 800 guidelines. The chemotherapy cleanroom is kept under negative pressure to protect the pharmacist, the patients, and the environment from any harm due to the compounding of chemotherapy drugs. The chemo room, like the IV room, needs to be a sterilized environment. Mecart’s modular facilities offer safe and sterile cleanroom areas where you can control humidity, temperature, airborne particles, and pressure which will guarantee the quality of the medicine, from the oncology pharmacy to your patients.

MECART’S Modular Buildings: Guaranteed Performance & Compliance

Mecart clean rooms are manufactured in our own plant where we control the whole manufacturing process with high-quality standards.  Our expertise and experience can guarantee the performance of our modular cleanrooms. Our clean rooms are also compliant for:

• USP 797 / USP 800
• 503A, 503B
• ISO 5 to ISO 8
• GMP grade A, B, C and D