✕
☰

Pristine condition with WH Partnership's cleanrooms

by

Building an effective cleanroom facility ­­– an inside-out approach by John Challenger, WH Partnership

From small start-up enterprises to established major international pharmaceutical companies and their supply chain, manufacturers and researchers require cleanroom facilities that will achieve quality and operational standards to meet the expectations of the regulatory bodies but most importantly work effectively and are value for money. Clients increasingly expect that facilities can be designed, built and qualified in extremely short timescales. These are all reasonable expectations but it is essential that both the client and the cleanroom contractor work closely to define the requirements prior to the start of any project.

At WHP we recognise that integrating manufacturing plant and equipment into a cleanroom is fundamental to ensuring that the facilities will meet client expectations regarding time and cost. No matter whether a new cleanroom facility is to be installed in an existing or a bespoke host building, we adopt an ‘inside out’ approach, treating the cleanroom as part of the process or manufacturing plant design.

There are very few companies in the UK, USA or mainland Europe that combine the full design and construction capabilities for both process plant and cleanrooms in a single organization. This is surprising since integration of the two essential facets of clean production activities is paramount in the successful outcome of projects in the clean industry sectors. This approach to cleanroom design is not new and WHP was part of an association started in the 1980s adopting this methodology which was shown to deliver cost and time effective facilities.

Definition and validation

For companies supplying medical plastics or products that involve the production of filled medicinal or healthcare products that use, for example Form Fill Seal machines, the way in which equipment is integrated into cleanrooms requires the same attention to detail and regulatory compliance as that needed by the pharmaceutical industry. Clearly the quality of the cleanroom and its operating environment will depend on the product application and on the manufacturing standards imposed by the end user. Such standards can vary from simple clean manufacturing conditions that will prevent any plastic component from becoming contaminated to the use of aseptic conditions for products that will ultimately have direct internal patient contact.

Another significant factor affecting how the cleanroom might be designed and operated is the level of containment that barrier or isolation technology can provide. Many plastic moulding and filling machinery is legally required to be provided with safety guards or barriers that could be modified to create a specified environment in the critical manufacturing zone (the area immediately around any point of filling, moulding zone or through which any manufactured component is to pass). The way in which a cleanroom is specified will therefore depend on how the machine and its barrier are to operate and the potential contamination challenge from the surrounding area when in operation.  The advantage of using barrier technology is that if it can be demonstrated that the critical manufacturing zone can be maintained throughout the manufacturing cycle then it may be possible to specify a lower environmental classification than would otherwise be required and reduce the capital and operating cost of the surrounding cleanroom. This type of isolation technology has been successfully operated since the 1980s and has demonstrated significant reduction in cleanroom operating costs.

The development of a manufacturing process-led user requirement brief or specification is essential to the development of a successful operating clean room.  In this context the initial development of a materials/process flow diagrams, adjacency diagrams and equipment list with sizing data are all prerequisites of being able to develop accurate room data sheets that will fundamentally describe each clean room and its operating requirements. So often, cleanrooms are developed without this fundamental data being in place which leads to failures in quality, purchaser disappointment and sometimes dispute. The other helpful element in the development of cleanrooms is the early involvement of the regulators, particularly when novel processes are to be carried out.

Inevitably for medical plastic products including polymeric packaging, particularly those which are either defined as medical devices or are used to contain parenteral, licensed or over-the-counter pharmaceuticals (OTC), appropriate levels of facility and product qualification needs to take place. The commissioning and validation of any clean room must be considered as part of the overall product quality control and assurance for the product and in order to adequately manage the process, it is first necessary to establish a thorough validation master plan (VMP).

The production environment, cleanrooms and utility services that are critical to product quality will all need to be validated by undertaking installation qualification (IQ) and operational qualification (OQ). It should be noted that it is of considerable importance to establishing a reliable VMP that the user requirement brief, or in the case of the cleanrooms, a facility requirement specification has been thoroughly developed and approved by the company, relevant departments or person responsible for the overall product quality control. The extent of the validation procedure will depend on several factors, including the expectation of the specific regulatory body that will licence the facility and products, any involvement of major companies that may have their own extensive quality procedures and of course the type and use of the product being manufactured.

Back to basics

Generally speaking, clients and people working in facilities know what they want but not always how they want to achieve it. Our job is to listen to them, interpret what they say and advise on possible solutions. It is often found that three-dimensional space awareness and planning are not fully understood by the users. The design needs to be demonstrated effectively to enable them to understand not only how the operating and maintenance staff will interface with the manufacturing equipment but how the manufacturing equipment will interface with the cleanroom. This is a particularly important facet of design when large moulding machinery is to be installed which often requires reasonably frequent removal and installation of mould or change parts to meet the requirements of production campaigns.

Of equal importance is the project management methodology adopted, particularly at the development stages of a project. WHP has found that a stage gate approach provides the technical and financial controls necessary to monitor each stage in the design or build process. This concept allows us to consider a range of options and choose the most suitable for each client or project.

Recognising the need for the efficient transfer of information from the client or user, WHP has developed its own detailed check list of basic requirements to enable the full range of design parameters to be defined for the cleanrooms we are required to build. The following are some fundamental questions we ask:

Go with the flow

Once the user requirement brief is properly established and linked with a full understanding of the manufacturing process and standards, the design can be started by developing the following:

Once all of these operating features, location and essential services are agreed, designing a cost-effective facility which suits the client’s requirements and deliver the facility in a short timescale can become the focus. The success of this approach was demonstrated recently with a project for TC BioPharm in which a facility containing cleanrooms, quality control suites and development

laboratories designed to support the manufacture of clinical grade product was constructed in just 12 weeks from start to finish and was granted a license to produce human cell therapy products by the Medicines Healthcare Products Regulatory Agency (MHRA). This was achieved by establishing a close working relationship with the client and taking the time to define the operational requirements of the facility.

Back to topbutton