Where can Advipro make a difference when (re)building a cleanroom?
A new royal decree "on the preparation and delivery of medicines and the use and distribution of medical devices within care institutions" was recently published. Specifically, it is expected to work in controlled environments, namely clean rooms.
For many hospitals, laboratories, start-ups and other organisations, building and validating a cleanroom in compliance with (new) regulations can be a big step into the unknown, often lacking specific expertise. By engaging Advipro, you gain access to targeted expertise and support to successfully complete your cleanroom project. It is essential to ensure quality during the implementation of changes and improvements in an innovative and validated production environment. This contributes to improved long-term cost efficiency, as every decision can have an impact on the final commissioning.
Advipro has built up years of experience and know-how in the Life Sciences & high tech industry where very strict regulations are applied and often large complex projects are realised. Through this experience, Advipro's staff are well placed to translate the industry's operating principles and established methods and processes to your project.
Through this experience, Advipro has developed its own CLeanroom IMplementation Blueprint (CLIMB) to advise and support cleanroom project teams throughout the entire process, with accompanying deliverables.
Process mapping
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. We ask the necessary questions to collect everything.
Design
To gain a good overview of all the flows that will take place in the clean room, Advipro creates flowcharts, among other things. 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, Advipro can always be consulted to perform an independent GMP review. The result is a clear report with recommendations and comments.
QRM
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 at Advipro 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").
URS
The importance of a User Requirement Specification (URS) is made clear right from the start. Through the various process mapping sessions, Advipro can help in clarifying 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, Advipro can also assist in negotiations with the contractor and suppliers. The URS documents are then also used when preparing tender forms.
QMS
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 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.
Commissioning
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.
Qualification
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).
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.
Validation
Advipro itself 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. Even more, they can also validate your sterile processes, devices and utilities, such as the sterilisation cycle of an autoclave.
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.
Monitoring
Even after the cleanroom has been released for production based on a summary validation report, Advipro will not let you down. After all, according to regulations, the cleanroom must be monitored continuously to guarantee quality. For carrying out periodic re-qualifications, risk analyses, mappings, root cause analyses, setting up internal audits, etc., you can always reach out to us.
Project Management & Consulting
As true experts in cleanrooms, sterile processes and quality systems, we can of course provide even more different services for your hospital, laboratory or start-up.
In this way, the entire cleanroom project can be coordinated by an experienced and skilled Project Manager. He or she organises, prepares, plans, follows up and strives to deliver the project on time and within budget. To this end, the Project Manager transparently cooperates with external contractors and the many experts within Advipro.