Where can Normec Advipro make a difference when (re)building a cleanroom?

A first important step in the process is to know and then document the (own) processes and working methods that will occur in and around the cleanroom. For example, aseptic work, sterile gowning, waste flows, the maximum number of staff using the cleanroom at the same time, where to store product, what kind of equipment to use, which consumables are needed and so on. Our experts ask the right questions to gather all the necessary information.

To gain a good overview of all the flows that will take place in the clean room, Normec Advipro creates flowcharts, among other tools. These are then used to look for the most efficient flow of people and goods and serve as important input for drafting the preliminary design, from which the final detailed design follows.

During the design process of the floor plan, Normec Advipro can always be consulted to perform an independent GMP review. The result is a clear report with recommendations and comments.

An important task as a quality manager is to minimise and, where necessary, mitigate all risks. In other words, you carry out Quality Risk Management (QRM) throughout the entire process.

To get a clear overview of the risks and associated strategies, a risk analysis is usually carried out. Besides having extensive knowledge of performing risk analyses in GMP environments (regular pharmaceutical industry), we are also familiar with performing risk analyses for hospitals and high-tech start-ups. Although the basic principles are the same, there are different emphases. We can therefore provide the necessary templates and explanations here, or even facilitate the entire session until the document is delivered. The main importance of performing these analyses is clear: reducing risks ("ensuring safety").

The importance of a User Requirement Specification (URS) is made clear right from the start. Through the various process mapping sessions, Normec Advipro can help clarify the necessary and desired requirements. This can range from facilitating the formatting of the URS document to full management of the document and its delivery. Where required, we can also assist in negotiations with the contractor and suppliers. The URS documents are then also used when preparing tender forms.

An important aspect of producing and working with medicines is ensuring reproducibility using documented working methods and procedures. This involves the necessary maintaining and processing of information and documents such as certificates, user manuals, measurement results, procedures, risk analyses, change management, qualification and validation reports. One of Normec Advipro's strengths is (helping to) create all this information, bring it up to date, keep it clear and ready for possible audits.

Among other things, standard operating procedures (SOP) are a very important part of the Quality Management System (QMS). By checking that all necessary SOPs are provided, the continuous quality of drug preparation and delivery within care facilities is monitored.

After building the cleanroom, it is important to devote sufficient attention to commissioning in order to avoid surprises during the qualification phase that will result in delays causing longer lead times of the qualification and validation phase. As an independent party, we are therefore often called in to closely support commissioning documents and execution.

To formally demonstrate that the high-tech cleanroom and systems were installed and operate as described in the URS, the whole thing is validated. This always follows a predefined qualification strategy, defined in the VMP. Namely, a validation of the installation (IQ), operation (OQ) and system performance (PQ).

Normec Advipro excels in drawing up, reviewing and executing qualification documentation: protocols, test forms and reports.

A first protocol, for instance, deals with the finishing of rooms, checking whether the right materials have been used, whether the desired degree of finishing has been achieved and whether there are no places where dirt can accumulate. Another protocol then describes the necessary utilities and associated tests, including the installed gases and water systems (PW, WFI, etc.).

The number and classification of these protocols depend on what other requirements are described in the URS, such as monitoring and alarm systems, testing the software packages used or tests for specific equipment such as biosafety cabinets or isolators.

Normec Advipro has a team of Mobile Validation Experts (MoVE) who come to your cleanroom with high-tech equipment and perform all the tests described in the qualification protocols. They can also validate your sterile processes, devices and utilities, such as the sterilisation cycle of an autoclave.

Normec Advipro's supplied support can range from just reviewing supplied documents to working out specific test methods and delivering the full package of protocols, sampling plans, results, reports and conclusions.

Even after the cleanroom has been released for production based on a summary validation report, Normec Advipro remains at your side. After all, according to regulations, the cleanroom must be monitored continuously to guarantee quality. For periodic requalifications, risk analyses, mappings, root cause analyses, setting up internal audits, and more, you can continue to rely on our support.