Biopharmaceutical Facility Design and Biocontainment
Modular pharmaceutical and biopharmaceutical cleanroom production facilities are complete turnkey units that are designed, engineered and manufactured off-site. Upon completion, these modules are factory acceptance tested prior to being shipped for final installation. This assures that upon delivery, all critical systems are precisely configured, compliant and fully operational.
Modular facilities provide a unique range of options for the biopharmaceutical industry when adding new products, which often require new processes. These flexible manufacturing platforms add capacity that is tailored to the specific requirements of any bio/pharmaceutical project. Modular pharmaceutical manufacturing allows for new space with enhanced quality assurance and faster project completion. This method of biopharmaceutical facility design also mitigates any disruptions to current operations.
Pharmaceutical facility planners face unique challenges when adding capacity. Many strategic engineering and logistical factors play a critical role when expanding current operations, adding processes, bringing new drugs to market, development and production of new vaccines/biologics, as well as adding capabilities for research. Modular pharmaceutical manufacturing is the optimal platform for turnkey units that are designed specifically for new projects. Utilizing modular biopharmaceutical solutions also helps facility engineers maintain timelines and cost certainty while assuring adherence to all design specifications.
Modular Biopharmaceutical Facility Design
Many legacy biomanufacturing buildings were designed prior to the most current cGMP regulations. Additionally, these structures often have HVAC systems that are energy-inefficient or not properly isolated from other operations. Modular pharmaceutical manufacturing solves these problems by providing self-contained, energy-efficient HVAC and air filtration systems.
Modular pharmaceutical manufacturing provides the most flexible platform available; giving pharmaceutical building engineers a new range of options. Biopharmaceutical facility design can be readily focused on changing product requirements, capacity demands as well as new R&D initiatives. Once a project is completed, modular units can be repurposed for other pharmaceutical processes.
Modular biopharmaceutical facility design can also provide many benefits for greenfield projects. Modules are efficiently added as they are needed to boost capacity or meet the production demands for new products. This method can reduce initial capital costs for new pharmaceutical projects.
Modular Pharmaceutical Manufacturing & Biocontainment
Biopharmaceutical facility design must incorporate a range of environmental controls. Aside from cGMP and aseptic demands, many applications require advanced biocontainment Modular pharmaceutical manufacturing is ideal for these projects as the modules are completely segregated from all other operations. The units have self-contained filtration/HVAC systems that eliminate the possibility of cross-contamination with other processes.
In Pharmaceutical Biocontainment facilities, all production equipment and process components must be seamlessly integrated to provide a safe, optimal workflow. It is imperative that the biopharmaceutical facility design promotes biological safety during any type of regular operations. This allows R&D or manufacturing activity to be conducted without ‘breaking containment’. It is also critical that the modular facility support the ingress of sterile products and egress of contaminated materials while maintaining biocontainment.
Biopharmaceutical manufacturing facilities incorporate stringent sanitization and sterilization protocols as part of normal SOPs. Pharmaceutical Biocontainment operations have additional specialized requirements for disinfection, decontamination and the handling of contaminated materials. These facilities may utilize gas/vapor sterilization and decontamination systems, effluent decontamination or other methods to fit the specific application. Lines of biosafety equipment such as Class III Biological Safety Cabinets and isolators are also engineered with integrated decontamination systems.
Modular Biocontainment facilities must be constructed from highly durable and resistant materials that can be easily cleaned, sanitized and withstand decontamination agents. Interiors should be monolithic and sealed with flooring coved up the wall. Arcoplast solid glass/resin core panels are the ideal material for ceiling and wall panels as they meet ASTM standards for resistance to mold, fungi, bacteria and do not support microbial growth.
BSL-3 Modular Pharmaceutical Applications
Technological advancements in modular biosafety engineering allow for high levels of containment, up to Biological Safety Level 3 (BSL-3 and ABSL-3). These facilities support all cGMP biomanufacturing processes while concurrently maintaining the specified biological safety level. BSL-3 operations have specialized HVAC and air-filtration systems as well as advanced controls to meet the requirements for secondary containment. Additionally, all primary containment equipment must be properly integrated into the modular units.
Germfree is the only company that designs, engineers and manufacturers all the critical primary containment equipment and secondary containment systems for modular BSL-3. These turnkey facilities also meet all cleanroom, cGMP and aseptic requirements for any modular pharmaceutical manufacturing application.
Additional information is also available about Germfree’s Integrated Modular.