Development & Operations

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Solutions designed to accelerate your product and process development.

Product & Process Development:

Our biopharmaceutical, medical device, and packaging experts establish and improve manufacturing processes guided by Quality by Design (QbD) principles. We integrate product and process development to create practical and speedy solutions. We can assist with technology transfers of biologics and pharmaceuticals.

Process Engineering:

Advanced Cleanroom Services has experts in design of manufacturing facilities, process tech transfers, process equipment, and process support across the biotechnology and pharmaceutical industries, 

including novel therapies. We help you get your product to market and keep it there.

We conduct feasibility studies and support architectural/engineering and construction management companies in developing conceptual and design packages. We can also work as the client rep directing these companies.

Our experience includes tech transfer strategy and execution, including documentation, from process development to scale-up to manufacturing. This includes transfer of processes to different locations.

Process equipment sizing, data sheets, piping & instrumentation diagrams, purchase specifications, vendor selection, bid analysis, engineering support during fabrication of equipment, acceptance tests, and validation.

We have extensive experience with manufacturing campaign support, problem root cause analysis, and issue resolution. We help write deviations, CAPAs, investigations, campaign summary reports, and annual reports.