Clean Room Designers

Clean Room Designers

pharmaceutical clean room designers and validation

PharmOut is a multi-disciplinary team of expert pharmaceutical architects and engineers, we are Australia’s leading pharmaceutical clean room designers, working for cosmetics manufacturers, non sterile and sterile pharmaceutical manufacturers around the world to provide Architecture and Engineering services.

Manufacturers, often set a challenge for PharmOut’s process engineers to scale up or replicate processes. PharmOuts standard approach is to obtain a product list from the client. Once we have an understanding of the product mix and growth targets we can start designing the clean room to house the process. Once the clean room is wrapped around the process the supporting critical services are connected to the process. Our architects the ensure that the design and scale up of the the processes and manufacturing areas are in harmony with the client intent. We are experienced in ensuring that the clean rooms are designed and then specified to the exacting regulatory standards of the FDA, EU and the TGA. The clean room specifications are used to obtain quotations from builders, aside from ensuring that the facility is fit for purpose, the specification ensure prices are comparable, i.e. compare apples with apples.

In addition to being engaged as the Clean Room Designers, PharmOut, as an additional service are able to provide expert GMP, regulatory and validation support and apply the principles of Lean design, enabling the optimised manufacturing state of the art facility for the manufacturer.

PharmOut are earning an enviable reputation in the pharmaceutical cosmetic industry as the designers of choice, with a recent track record of designing 4 cosmetic facilities in the last 12 months. These are at various stages of completion.

The specification is used to validate, i.e. test the design, often final payment can be withheld pending successful testing of your clean room.

Download your clean room checklist or see one of the many presentations shared by our consultants.

2015_GMP_Validation_Forum_D2.T4.3.3 - Bernie Prendergast - Temperature and humidity mapping of cleanrooms