Flexible Facilities Implementation
Facilitate implementation and changeover of flexible facilities, integrating single-use technologies with flexible manufacturing operations
Type
Functional
Competency Area
Production
Levels
Operate and use flexible facilities in biopharmaceuticals manufacturing
Prepare portable or single-use manufacturing technologies and other flexible facilities
Move portable manufacturing equipment, machinery and materials as instructed
Rinse single-use assembly surfaces as instructed
Connect flexible facilities equipment and parts according to instructions
Start up single-use equipment according to SOPs
Operate single-use technologies during biopharmaceuticals production
Dispose single-use equipment safely and in accordance to standard protocols
Locate and interpret information in Safety Data Sheets (SDSs)
Document flexible facilities set-up activities performed
Implement single-use equipment and other flexible facilities in biopharmaceuticals manufacturing plants
Oversee preparation of portable or single-use manufacturing technologies
Install single-use facilities with fixed process equipment
Check integrity of flexible facilities equipment and parts set-up
Prepare filters and rinsing fluids for integration into single- use assemblies
Monitor usage of single- use assemblies and associated rinsing processes for alignment with cleanliness and quality standards
Disconnect single-use assemblies and facilities from process equipment to allow for changeovers
Reconfigure flexible facilities and equipment as directed to accommodate scaling up of production
Develop guidelines and procedures for the changeover and implementation of flexible facilities
Oversee product and facility changeovers for multiple product lines
Add or remove unit operations based on biopharmaceuticals products manufacturing needs
Set targets and guidelines for facilities changeover time
Establish flexible facilities or single-use equipment cleaning and rinsing requirements within flexible facilities
Lead teams to facilitate changeovers of facilities
Establish organisational directions for the use of flexible facilities and single- use equipment
Advise on flexible facilities feasibility assessments from biopharmaceuticals products and processes perspectives
Direct suitable placements of flexible facilities and equipment for manufacturing of different products
Establish organisational processes and Standard Operating Procedures (SOPs) to set up, operate, clear out and change over flexible facilities and single-use technologies
Guide use of flexible facilities with the scaling up of production from clinical trial material runs to commercial manufacturing scales
Review evaluations of flexible facilities success and determine if they should be continued
Troubleshoot multi- disciplinary issues with flexible systems