Newsletters Subscribe. RABS are ideally suited for handling sterile, non-hazardous products. This is important for reducing the potential for cross-contamination. We typically use powered air purifying respirators as a failsafe, and some specific processes might require items such as special gloves or suits. The former is more appropriate when handling potent compounds. Occupational health must be taken into account across the board, from the time any potent material enters or is made in the facility, to the time it leaves as a final dosage form.
Unidirectional flow occurs when the flow of people, material, and equipment goes Figure illustrates a potent compound suite design with separate gowning.
trends, Regis intends to add potent compounds handling to its services. Our plan for laminar flow hoods, and local exhaust ventilation appropriate for potent.
Introducing potent compounds (anywhere) Self contained full process / product suites (“all in”) Unidirectional flow eliminates cross over and confines.
Before deciding whether to use that OEL, it is important to know whether it is based on human data, and what studies were performed to determine it. As we may handle many different products and projects in our multipurpose facilities, we need to mitigate the risk of cross-contamination, and the attendant risk to patient safety.
Pharmaceutical Weighing Weighing and Dispensing Do it Right Pharmaceutical Manufacturing
For example, in our oral solids manufacturing facility in Somerset, NJ, the plan consists of two parallel pathways. The effectiveness of containment is verified by performing industrial hygiene studies.
Is it a known mutagen, carcinogen or genotoxic agent?
SOLID DOSAGE, POTENT COMPOUNDS, RESEARCH Normal 0 false false The program consisted of a sterile filling suite and an oral solid dose clinical facility for potent compounds. Both designs were based on unidirectional flow. Are potent compounds involved/handled? One-way flow is always preferred, as long as all other needs.
Pharmaceutical RABS Pharmaceutical Isolators & RABS Germfree
From clean clothing to full coverage suit.
Germfree has extensive experience in manufacturing custom barrier systems that meet the most stringent fabrication standards. These units operate within a cleanroom environment with a minimum standard of ISO 7. RABS mitigate the risk of contamination to sterile materials, containers, vials or surfaces that may come into contact with the product.
This is all part of our formal onboarding process for compounds and projects.
Catalent's Holistic Approach to High Potency API Operations
Containment reduces the risk of cross-contamination and, when matched with the correct cleaning methods, leads to a reduction in regulatory risk, and, further down the line, minimizes the risk to patients. Again, higher numbers are preferred for potent compounds. The effectiveness of containment is verified by performing industrial hygiene studies.
Unidirectional flow in potent compound suite
|The starting point for exposure control is the facility infrastructure.
Biopharmaceutical applications that involve handling highly potent products, toxic APIs or dangerous pathogens are conducted in Pharmaceutical Containment Isolators.
Video: Unidirectional flow in potent compound suite Tour the Metrics Potent Facility
Containment reduces the risk of cross-contamination and, when matched with the correct cleaning methods, leads to a reduction in regulatory risk, and, further down the line, minimizes the risk to patients. Hazard is the potential for a compound to produce harm.
Video: Unidirectional flow in potent compound suite Tech Tutorial: Vmax™ Constant Pressure Test For Sizing Aseptic Filters
Risk assessment is essential, and must be done before manufacturing or onboarding compounds to ensure the best solution for that particular case is chosen. A key consideration is the proper engineering of air handling and filtration systems. Pharmaceutical applications range significantly in their scope and requirements.