Kymanox has been designing GMP facilities since its inception. We provide upfront facility design layouts and partner with other engineering firms to produce facility permit drawings. In addition, we offer assistance with facility location selection.
Kymanox have produced the conceptual designs for a wide range of GMP manufacturing buildings: Pharmaceutical (Solid and Liquid Dosage); sterile and non-sterile fill; label and pack; biotechnology; medical device; compounding pharmacy; single use (disposable); and cell and gene therapy facilities. Facility designs have included greenfield sites, existing facility upgrades and retrofits, and facility expansions, and from the small facilities to $100MM+ facilities.
Kymanox can also review existing designs, and designs by other engineering companies. Kymanox can also provide a decision matrix (MCDA) to objectively determine which layout options best meet a client’s needs. Options can be developed with emphasis on throughput, optimal layout, cost or schedule. Documentation of the design and the development of the design are critical parts in the Design Qualification of a facility, recommended by the regulatory authorities in the U.S, Europe and Japan, among others.
Kymanox’s Quality and Regulatory Compliance groups assist in reviewing facility designs, to ensure designs are compliant with FDA, EMA, JP Regulatory requirements. The Regulatory Compliance group will also confirm the cleanroom requirements for each manufacturing area, and airlock.
In addition, to developing facility layout options from scratch, we also use industry approved Best Practices for the various types of facility designs. Facility designs include manufacturing areas, lab space, utility rooms, electrical/ control rooms, Air handler locations, label and pack rooms, maintenance and metrology rooms, offices and warehousing. If Facility Layouts are included as part of a Feasibility or Conceptual design report, we will size equipment and rooms, and include in the facility layout.
Our Facility designs also come with GMP flows for raw materials, intermediates, product, buffers, personnel, waste, and HVAC. We also provide a write up of Facility Designs and their GMP flows, for use in Regulatory filings such as NDA’s, and Type A/B/C meetings with the FDA, and other regulatory bodies. For Facilities with Hazardous chemicals, Kymanox provide a write up for OSHA detailing the safety measures taken, and for facilities with controlled chemicals, Kymanox provide a write up for the DEA detailing measures to secure the controlled material.