Small Scale & Pilot

Small-Volume Manufacture of APIs

Purisys offers a flexible high-containment suite with controls in place to produce compounds of OEL<500 ng/m3, and systems in place to create NSP-grade APIs for parenteral applications (including milling capabilities). Special adaptations in suite design, equipment design, operations and process safety afford developers a single location to produce on a flexible, small volume GMP scale. They can then advance through clinical stages and finally to commercial production of small-volume APIs.

They can then advance through clinical stages and finally to commercial production of small-volume APIs.

cGMP Production
FDA-inspected commercial manufacturing facility.
Flexible equipment design to support gram to multiple kg scale.

Sterility
Class 100,000 clean room environment.
Additional design features and procedures to operate as class 10,000 for non-sterile parenteral grades.

High Potency
Ability to handle high potency and cytotoxic substances (OEL<500 ng/m3).
Closed-charge charging/discharging systems and equipment.

Labile Compounds
Processing of highly-sensitive materials – oxygen, light, heat and more.

At Purisys, we offer more than access to state-of-the-art suites. We provide:

  • An in-house team of chemists and engineers to help optimize small-scale manufacturing
  • Comprehensive analytical, regulatory, physical properties and stability support
  • Integration of quality by design to API & cannabinoid ingredient development and manufacture

Purisys reduces your time to market with a customer-focused and knowledgeable regulatory affairs team to supply comprehensive documentation, from IND support to commercial filings.

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