Sterility Testing and Compounding

At ISOFLOW, we design and manufacture state-of-the-art containment solutions tailored to the pharmaceutical industry’s most demanding applications. Our sterility testing isolators and compounding systems ensure compliance with current Good Manufacturing Practices (cGMP), delivering unmatched safety, precision, and efficiency. Trusted by industry leaders like the FDA, ISOFLOW’s innovative technology supports critical processes in sterility testing and pharmaceutical compounding. Discover how our solutions can elevate your operations.

Sterility Testing Isolators: Engineered for Excellence

ISOFLOW’s sterility testing isolators are purpose-built for cGMP sterility testing, offering robust protection for both products and operators. Available in two configurations, these systems cater to a range of testing needs:

C8 Model (8′ with 4 Gloves): Designed for high-volume sterility testing, featuring four glove ports for multi-operator use and maximum throughput.
C4 Model (4′ with 2 Gloves): A compact, mobile option ideal for smaller batches or material transfer, providing flexibility in dynamic workflows.

Both models boast ISO 5 unidirectional airflow, delivering a consistent vertical laminar flow of 60 feet per minute at 12 inches to maintain a sterile environment. Constructed with 316 stainless steel and tempered glass, our isolators combine durability with visibility, while inflatable gaskets on all transfer chamber doors ensure an airtight seal.

Integrated H2O2 (hydrogen peroxide) decontamination accelerates cycles and recovery rates, with a single Allen Bradley HMI/PLC controlling both the isolator and H2O2 generator for streamlined operation. This system efficiently decontaminates both C8 and C4 units, minimizing downtime. Key features include:

Millipore Sterility Pump Integration: Enhances testing efficiency.
Alpha Beta Doors: Secures material transfers.
Lift System: Optimizes ergonomics.

ISOFLOW provides a turnkey solution, including equipment integration, interfacing, start-up, training, and full validation (IQ/OQ/PQ), ensuring seamless cGMP compliance.

Compounding Solutions: Safety in Every Dose

ISOFLOW’s containment expertise extends to pharmaceutical compounding, where precision and safety are paramount. Our isolators are engineered to handle both hazardous and non-hazardous compounding, protecting personnel and maintaining product integrity. Leveraging the same advanced technology as our sterility testing systems, these solutions feature:

Vertical Unidirectional Laminar Airflow (60 ft/min at 12 inches): Ensures a contamination-free compounding environment.
Tempered Glass Doors with Inflatable Gaskets: Provides a secure, sealed workspace.
316 Stainless Steel Construction: Built for durability and compliance with stringent standards.

The mobile C4 model excels in transferring materials between compounding and testing areas, offering adaptability for complex workflows. With customizable configurations and H2O2 decontamination integration, ISOFLOW compounding isolators deliver the reliability and control needed for preparing sterile medications.

Why ISOFLOW?

Trusted by the FDA: Proven performance in real-world sterility testing applications.
Advanced Decontamination: H2O2 integration ensures fast, effective cycles.
End-to-End Support: From design to validation, we’re your partner in compliance.
Robust Design: High-quality materials guarantee long-term dependability.

At ISOFLOW, we’re committed to advancing pharmaceutical safety and efficiency. Whether you’re conducting sterility testing or compounding medications, our containment solutions set the standard for excellence. Contact us at 1-800-849-3429 to explore how ISOFLOW can meet your needs.