Flexible Facilities Implementation

Facilitate implementation and changeover of flexible facilities, integrating single-use technologies with flexible manufacturing operations



Competency Area



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