Design of an Award-Winning, Fully Integrated Dual Sterile Filtration Unit, With In-situ Integrity Testing and Elimination of Contamination Routes
Challenge from the Client
As part of a sterile facility upgrade, improvement of the existing, fully manual, sterile filtration stream, which consisted of two filters in series, with a number of hose connections, within a cleanroom, was required.
This project aimed to optimize the filtration process and eliminate risks involved with manual operations, and potential routes for contamination, to allow sterile filters to be operated and integrity tested with no quality risks.
The main objectives of the design were:
- To design an automated, sterile filtration system to transfer multiple products into a Grade C cleanroom and on to multiple vessels
- Allow for integrated and automated filter integrity testing, with complete protection of the sterile system boundaries during integrity testing carried out pre-sterilization, post-sterilization (preprocess use) and post-use
- Meet ATEX requirements
- Minimize the equipment within the clean room
- Allow for fully automated CIP and SIP
- Design to ASME BPE and GMP requirements
Our Approach & Solution
A multidiscipline team worked together with the suppliers of the preferred system components to translate the concept P&IDs into 3D models of the filter skid. Regular, iterative, reviews of the models took place to allow the team to work through and challenge the constraints of the design to ensure compliance with the ASME BPE and GMP requirements.
A unit was designed and built that achieved the following:
- Integrity of filters, and sterility of process, confirmed as final step prior to introduction of product (to confirm no damage during sterilization step)
- Integration with clean room panels to ensure only essential components are within the clean room
- Removal of all manual operations from the process, apart from replacement of the filter cartridges
- Reduction of plant set-up time with no off-line testing or manual setup
- Real time process monitoring
- Improved operator and environmental safety as whole operation is fully contained
The Results
Three filter skids were designed and built which were fully automated, and could undergo CIP and SIP, with hard-piped, in-situ integrity testing, with no potential routes for contamination during post-sterilization, pre-use, integrity testing.
The skids have reduced operational risks within the processing facility and enhanced the ability of the facility to maintain production and quality of output, improving the overall efficiency and cost effectiveness of the process.
The project won the inaugural Pharma Award at the IChemE Global Awards in 2018.
Related Molecules
Clinical Aseptic Spray Drying Facility Project
Read MoreIPS utilized the Inceptioneering process and expertise in aseptic spray drying technology for manufacturing APIs for formulation and filling.
Single-Use Mammalian Cell Culture Facility - Vial to Vial
Read MoreOur challenge was to design a biologics manufacturing launch facility within an existing shell & office building.
Replacement Powder Mill for Pharmaceutical Client
Read MoreAfter a previous remediation attempts from other consultants failed, IPS was brought in to solve our client’s excess temperature problems in their new milling equipment.
Potent Processing on Antiquated Equipment
Read MoreIPS experts provided the latest technical solutions to retrofit a facility to improve manufacturing processes.
Modular Design, Construction and Installation of QC Labs
Read MoreA copy/paste modular build from the UK to Spain that overcame hurdles from the UK’s decision to leave the European Union.
Innovative Commercial-Scale Parenteral Fill/Finish Facility
Read MoreUsing Facility of the Future design principles, IPS designed a world-class, flexible, 490,000sf. facility.
Fast-Track Project Delivery Model
Read MoreA vaccine manufacturer and distributor needed IPS’ expertise to meet an aggressive timeline for expansion of their production facility.
Detailed Process Piping
Read MoreSupporting a client’s dynamic business requirements to produce a near-fabrication-level model to reduce schedule time.
3D Modelling and Laser Scanning
Read More3D laser scanning used to coordinate and design a new PTW generation skid and pipework connections within an existing operating facility.
Next Generation Propellant Technology for Pharmaceutical MDI Applications
Read MoreIPS provided technical and site master planning expertise enabling new commercial opportunities within the MDI market sector.
Antibody Drug Conjugation Commercial Manufacturing
Read MoreApplied first class design tools and industry specific experiences to develop a greenfield site for commercial ADC manufacturing.
Mobile Modular Vaccine Facility
Read MoreDeliver a modular vaccine facility capable of being relocated anywhere in the world with minimal host facility requirements.
Delivering a New Building with Two Project Teams
Read MoreProvided a client and building tenant with construction management services for the interior fit-out of a new 50,000sf pharmaceutical testing facility while a separate vendor constructs the core & shell for the landlord.
Annex 1 - The Brave New World of Aseptic Regulatory Compliance
Read MoreAfter six years in review, the final emergence of Annex 1 in August 2022 has either been a consolidation of accepted practice and wisdom, or a rude awakening for many!
