Potent Processing on Antiquated Equipment
Challenge from the Client
Due to a business need and a lack of capacity in the company’s adjacent potent suites, our client needed to manufacture Band 3b potent materials in their existing areas on legacy equipment where these operations were not originally intended.
The client's facility operated based on a clean corridor premise. The clean corridors and processing rooms were supplied with the same grade of air, and the process rooms were negative to the corridor. This prevents particulate/contaminates from egressing into the clean corridor. The majority of processing rooms were not equipped with airlocks.
|
Classification |
Occupational Exposure Levels (µg/m3) |
|
|
|
|
|
|
Band Categories |
Band 5 |
Band 4 |
Band 3b |
Band 3a |
Band 2 |
Band 1 |
|
Band Levels |
< 0.1 |
0.1 to <1 |
1 to <10 |
10 to <100 |
100 to <1000 |
≥ 1000 |
Our Approach & Solution
Our team evaluated the industrial hygiene data near related processes, design, and processes associated with fluid bed processing (including granulation), compression, and coating to provide a gap assessment of the operations and provide a risk analysis with potential options to mitigate risk and enhance containment at designated locations and during specific operations.
Industrial Hygiene data had been collected near various locations associated with Fluid Bed, Compression and Coating operations in the manufacturing area to determine what operations/procedures result in higher exposures.
IPS evaluated the high risk areas and developed a series of mitigation methods (engineering controls, and operating procedures) to prevent risk to the operators.
The Results
IPS designed a flexible glovebag isolator solution to retrofit around the existing granulator, as well as several single-use closed connections at various other make/break points throughout the manufacturing process. IPS utilized local ventilation to provide secondary containment in specific areas of higher risk.
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.
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.
Design of an Award-Winning, Fully Integrated Dual Sterile Filtration Unit, With In-situ Integrity Testing and Elimination of Contamination Routes
Read MoreIPS experts designed a filter skid system to eliminate contamination risks related to manual operations.
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!
