GxP Project Management : Cleanroom Supplier Selection

Selecting a Cleanroom Supplier is one of the most critical steps for Life Science companies such as pharmaceutical and biotechnology companies involving advanced manufacturing techniques, where contamination control is essential. However, ZES experience highlights the importance of being meticulous in this decision, as a poor choice can lead to setbacks, compliance issues, and increasing costs.

In this case the cleanroom fan manufacturer confirmed that the fans specified by the Cleanroom Supplier were actually only suitable for retail or office premises!

The Cleanroom Supplier in question was later removed from the supplier selection process. Such a mistake could have cost thousands to rectify, not to mention the potential impact on the product or patient, if the design error had gone unnoticed.

Zener Engineering Services Ltd act regularly on behalf of GxP manufacturers, to ensure suppliers supply to the right specifications, standards and user requirements.

In this blog ZES further explore the process of selecting the Cleanroom Supplier.

When ZES started the cleanroom project in conjunction with a new Client, ZES knew the Cleanroom Supplier selection process was important. ZES had several initial meetings and received professional presentations from different vendors. The Supplier that the Client initially chose stood out with competitive pricing, a glossy business overview, and what to the Client and ZES seemed like a genuine passion for the project. The Supplier ticked all the boxes on paper: experience, capabilities, and familiarity with regulatory standards. Unfortunately, it turned out the Supplier were far less competent than they claimed.

Once a preferred Supplier selection was made, the Client asked ZES to subject the Supplier's proposals to more detailed technical scrutiny.

One of the first warning signs was that the preferred Supplier often provided overly optimistic timelines and assurances about their capability to meet the project's specific needs. For example, they assured ZES and the Client they could customise the cleanroom to maintain ISO Class 7 standards (Grade C ) and sustain a high turnover rate of filtered air. But once ZES started to ask specific technical questions, the reality became different. Every time ZES tried to address specific needs, the Supplier seemed unsure, often deflecting questions with vague responses.

Cleanroom Supplier Quote "This design will provide ISO Class 7 all day long."

However ZES found that the Cleanroom fans were deemed suitable only for office or retail purposes, and this was confirmed directly by the manufacturer of the fans.

Initial poor planning by the Supplier was evident from the beginning, but manifested itself once the Supplier learnt they were now the preferred supplier. In the opinion of ZES, the Supplier didn’t conduct a thorough assessment of the facility’s space, resulting in design inconsistencies that potentially compromised the cleanroom's effectiveness. For instance, they overlooked factors like airflow dynamics and contamination risks related to the Client's specific workflow. The initial design the Supplier proposed lacked some critical features, such as one instance of proper HEPA filter placement and necessary operational pressure differentials.

When ZES pushed back on these concerns, the preferred Supplier seemed unfamiliar with the nuances of such systems. They even tried to minimise ZES's Client's requirements to fit the Supplier's simpler design. This was the moment ZES decided to technically scrutinise in some detail the Supplier's proposed cleanroom plant equipment.

The Supplier assured the Client that their design would meet ISO standards, and against ZES advice, persistently tried to dissuade the Client from the need for a third-party independent qualification and validation exercise.

Once ZES found the technical unsuitability issue surrounding the cleanroom fans, it became clear that the Supplier concerned were not actually interested in compliance and the potential risks to the patient.

Thorough Due Diligence: Don't be persuaded by a compelling pitch and glossy brochure. ZES would strongly recommend looking for evidence of experience through case studies, client testimonials, and references. ZES recommends that you speak to the Supplier's past clients directly about their experience and satisfaction with the Supplier’s work.

Technical Knowledge: During the Supplier selection process, ZES recommends that Life Science manufacturers engage independent technical experts who will look after the Client's interests. Independent technical experts will be to asked more specific, technical questions. This helps to gauge the Supplier’s familiarity with the standards and technologies required for the Life Science Industry's specific manufacturing needs. If the Supplier struggle to answer or provides vague responses, it’s likely a sign the Supplier lack the technical expertise.

Clear, Detailed Contract: Make sure the contract specifies every detail about materials, standards, and timelines. Stipulate penalties for delays and substandard work to avoid issues later on. ZES advocate a detailed URS is generated, to ensure the Client asks for the right things.

Independent Technical Expert Oversight: Consider involving an independent technical expert consultancy such as ZES to oversee the entirety of the project, as corners can be cut behind the scenes at any time. An extra set of independent technical eyes can help spot potential compliance issues before they become major setbacks.

Continuous Monitoring And Verification: Don’t wait until the end to verify compliance. Conduct regular checks from day one, even during the tendering process. Verify compliance during every step of the project.