Exdron is a leading provider of cleanroom GMP validation services in Israel. We offer a full service from beginning until full validation. We will write all protocols and procedures for you and with you, from DQ to PQ. We will prepare you and your company for this certification and audit and conduct all the tests needed and deliver a detailed professional report.

Cleanroom GMP validation is a process of verifying that a cleanroom and its associated systems and equipment are designed, installed, operated, and maintained in accordance with the GMP standards and the specific needs of the product and process. Cleanroom GMP validation consists of four phases, Each phase can be described as follows:
• Design Qualification (DQ), is the first phase of the validation process. It ensures that the design of the cleanroom and its systems and equipment meets the user requirements specification (URS) and the regulatory requirements. DQ involves reviewing and approving the design documents, such as drawings, specifications, calculations, risk assessments, etc.
• Installation Qualification (IQ), is the second phase of the validation process. It ensures that the cleanroom and its systems and equipment are installed correctly and in accordance with the approved design documents. IQ involves inspecting and testing the installation, such as piping, wiring, calibration, labeling, etc.
• Operational Qualification (OQ), is the third phase of the validation process. It ensures that the cleanroom and its systems and equipment operate consistently and reliably within the specified parameters and limits. OQ involves testing and verifying the operation, such as airflow, pressure, temperature, humidity, particle count, filter integrity, etc.
• Performance Qualification (PQ), is the fourth and final phase of the validation process. It ensures that the cleanroom and its systems and equipment perform as intended under the actual or simulated production conditions. PQ involves testing and monitoring the performance, such as microbial count, recovery, contamination, etc.

Cleanroom GMP validation is applicable to any organization that operates a cleanroom for the production of pharmaceutical, biotechnology, medical device, or other products that require a controlled environment. However, some sectors and customers may require or prefer cleanroom GMP validation as a condition for doing business with them. For example, cleanroom GMP validation is essential for the industries that follow the guidelines and regulations of the World Health Organization (WHO), the European Union (EU), the US Food and Drug Administration (FDA), or the Israeli Ministry of Health (MOH). These are some of the most demanding and competitive sectors in the world, and they expect the highest standards of cleanliness and quality from their suppliers and partners.

Therefore, if you want to gain a competitive edge and expand your business in these sectors, you need to obtain cleanroom GMP validation as soon as possible.
Exdron has a team of experienced and qualified consultants who can help you with every aspect of cleanroom GMP validation. We can help you with:
• URS: We will help you define and document your user requirements specification (URS) for your cleanroom and its systems and equipment, based on your product and process needs and the regulatory requirements
• DQ: We will help you review and approve the design documents for your cleanroom and its systems and equipment, and ensure that they meet the URS and the regulatory requirements
• IQ: We will help you inspect and test the installation of your cleanroom and its systems and equipment, and ensure that they are installed correctly and in accordance with the approved design documents
• OQ: We will help you test and verify the operation of your cleanroom and its systems and equipment, and ensure that they operate consistently and reliably within the specified parameters and limits
• PQ: We will help you test and monitor the performance of your cleanroom and its systems and equipment, and ensure that they perform as intended under the actual or simulated production conditions
• Report: We will deliver a detailed professional report with the validation results and the certification of your cleanroom and its systems and equipment

Exdron offers competitive and transparent pricing for our cleanroom GMP validation services, and we guarantee that you will get the best results, value, and speed of processing for your money.