Cleanroom Support: CLIMB
Welcome to Advipro, where innovation and expertise come together to elevate your cleanroom project to new heights. With our years of experience and the unique Cleanroom Implementation Blueprint (CLIMB), we demystify the unknown, providing your organization with the guidance and support necessary for a successful project journey.
1. Processmapping
A crucial first step in our journey is thoroughly understanding and documenting the processes and procedures that will occur in and around your cleanroom. From aseptic working to managing waste flows, from determining the maximum personnel in the cleanroom to the proper storage of products - we scrutinize everything.
Our team asks the right questions to gather all essential information. This ensures that we attain a comprehensive understanding and can precisely tailor your cleanroom project to your specific needs and requirements.
2. Design
Advipro lays the foundation for streamlined operations in your cleanroom. We start by creating detailed flowcharts to visualize all processes. These flowcharts are key to identifying the most efficient flow of people and goods.
Our expertise is further applied during the layout design process. Customers can always rely on our independent GMP review. The resulting report provides a clear overview with valuable recommendations and comments, ensuring the final detailed design is optimized to perfection.
3. QRM
As a quality manager, it's your responsibility to minimize risks and mitigate them where necessary. Quality Risk Management (QRM) is essential for this purpose and is applied throughout the entire process.
At Advipro, we understand the importance of thorough risk analysis and the development of appropriate strategies. In addition to our extensive knowledge of conducting risk analyses in GMP environments (regular pharmaceutical industry), we also have experience in conducting risk analyses for hospitals and high-tech start-ups. While the basic principles remain the same, there are different emphases. We can provide the necessary templates, offer explanations, or even facilitate the entire session until the document is finalized.
The ultimate goal? Reducing risks and ensuring safety.
4. URS
At Advipro, we recognize the importance of a User Requirement Specification (URS) from the start of every project. During our process mapping sessions, we assist in clarifying the necessary requirements and desires.
Our support ranges from facilitating the drafting of the URS document to its full management, including delivery. Additionally, if needed, we provide assistance in negotiations with contractors and suppliers.
URS documents play a crucial role in drafting tender forms, ensuring a clear and structured process.
5. QMS
In the production and handling of pharmaceuticals, ensuring reproducibility is essential. This requires documented methods and procedures, as well as the tracking and processing of various documents, such as certificates, user manuals, measurement results, procedures, risk analyses, and qualification and validation reports.
At Advipro, we specialize in drafting, keeping up-to-date, and systematically organizing this crucial documentation. Our strengths lie in ensuring all information is prepared for potential audits, enabling you to confidently comply with regulations.
Standard Operating Procedures (SOPs) are an integral part of the Quality Management System (QMS). By ensuring all required SOPs are in place, we continuously monitor the quality of pharmaceutical preparation and delivery within healthcare facilities.
6. Commissioning
After constructing the cleanroom, it is crucial to pay sufficient attention to commissioning. This ensures a smooth transition to the qualification phase, preventing surprises and delays.
As an independent party, we are often engaged to support commissioning documentation and execution. Our expertise helps ensure that everything proceeds according to plan, resulting in an efficient turnaround time for the qualification and validation phase.
7. Qualification
To ensure that high-tech cleanrooms and systems meet the specifications outlined in the User Requirement Specification (URS), they undergo thorough validation. This process follows a carefully determined qualification strategy, documented in the Validation Master Plan (VMP), and includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
At Advipro, we specialize in drafting, reviewing, and executing qualification documentation, including protocols, test forms, and reports.
The validation protocols are diverse and tailored to the specific needs of your cleanroom project. From verifying the rooms for correct materials and finishing to testing utilities and installations, including gases and water systems (PW, WFI, ...). The number and layout of the protocols are based on the requirements outlined in the URS, such as system monitoring and alarming, testing software packages, and specific equipment like biosafety cabinets or isolators.
8. Validation
Our Mobile Validation Experts (MoVE) come directly to your cleanroom with state-of-the-art equipment. They perform all tests described in the qualification protocols. And that's just the beginning. Our experts can also validate your sterile processes, equipment, and utilities, such as the sterilization cycle of an autoclave.
Our support extends from simple document review to the development of specific testing methods. We provide a comprehensive package of protocols, sampling plans, results, reports, and conclusions.
9. Monitoring
After your cleanroom is approved for production based on a thorough validation report, Advipro remains committed. Compliance regulations mandate continuous monitoring of the cleanroom to uphold quality standards.
From periodic requalifications to risk analyses, mappings, root cause analyses, and internal audit setup, we're your dependable partner. Count on our ongoing expertise and support to maintain your cleanroom effectively.
10. Project Management & Consulting
As experts in cleanrooms, sterile processes, and quality systems, we naturally offer a wide range of additional services tailored to your hospital, laboratory, or startup.
Imagine having the entire cleanroom journey coordinated by an experienced and skilled Project Manager. They organize, prepare, plan, monitor, and strive for timely project completion within budget. Collaborating transparently with external contractors and the numerous experts within Advipro, the Project Manager ensures seamless execution every step of the way.
Looking for support for your cleanroom project?
