About Us

FDA Registration 503 B Outsourcer

At Brookfield Medical Surgical Supply Inc. (BMSS), our staff is dedicated to producing safe and effective products for our patients. We are a 503B Outsourcing Facility registered with the FDA since January 2015. All of our operating procedures are carried out in compliance with cGMP guidelines. At BMSS, we operate under the highest standards of quality in every aspect of production. One major focus of importance at our facility is establishing and maintaining a safe environment for the manufacturing of sterile products. Achieving an ideal environment is a result of meticulous procedures in combination with an extensive environmental monitoring program. Extensive cleaning procedures paired with an automated 24/7 monitoring system of temperature, humidity and pressure readings contribute to establishing and maintaining an ideal environment. A safe environment is imperative when compounding sterile products, as it contributes to the safety and quality of the product. At BMSS, we are constantly striving to achieve the highest level of quality while keeping patient safety our top priority.

Our staff is comprised of well-trained pharmacists and compounding technicians with a great knowledge and understanding of cGMP rules and regulations. All compounding staff members are monitored and evaluated regularly on their aseptic technique to ensure that all compounding procedures are performed cleanly and consistently. Continuous training is carried out for all employees throughout the year in order to stay current on the latest changes and most recent guidelines.

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State of the Art Cleanrooms and Procedures

• Brookfield Medical & Surgical Supply cleanrooms utilize ULPA filters which have a greater efficiency than standard HEPA filters.

• Clean room certification performed every six months

• Validated equipment and procedures

• Calibration of autoclave, oven, incubators performed every six months

• Environmental Monitoring

    • Viable and non-viable particle counts (air sampling) performed daily under dynamic conditions

    • Environmental testing (surface sampling) performed daily under dynamic conditions

    • Fingertip sampling is performed at the end of every compounding shift

    • Temperature, humidity and pressure differential readings are continuously monitored by an automated system 24 hours a day, seven days a week

• Gowning Procedures

    • Sterile coveralls, boots, goggles and hoods are worn

    • No exposed skin in the cleanroom

    • Gowning procedure validated every six months

• Extensive testing performed on every lot of compounded sterile product (CSP) prior to release- Test results of all lots available upon request

    • Sterility tested

    • Pyrogen (endotoxin) tested

    • Potency tested

• Cleaning Procedures

    • Rigorous daily cleanroom cleaning procedures are carried out after completion of compounding shift

    • Rotation of cleaning agents including sporicidal agents

    • Additional weekly and monthly scheduled cleaning procedures performed

We are dedicated to supplying quality products for office use