Royal Liverpool Hospital
New Aseptic Cleanroom Suite Validation
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B, C & D Grade
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750 sqm
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MHRA
The Royal Liverpool Hospital is a highly regarded healthcare facility that provides a wide range of patient services. A requirement to build a new state- of-the-art Aseptic Cleanroom Suite was part of the construction project for the new hospital. This facility was designed to house a variety of critical pharmaceutical processes including Cytotoxic, Total Parenteral Nutrition (TPN), Central Intravenous Additive Service (CIVAS), and Gene Therapies.
Background to the project
The new suite is a complex arrangement of Grade B, C and D cleanrooms with eight large Grade A VHP gassing isolators throughout. It comprises 750m2 of critical classified cleanroom space served by three separate main AHU plants and eight dedicated isolator extract fans. Other features include an extensive environmental monitoring system along with numerous critical temperature-controlled spaces that comprise cold rooms, refrigerators and freezers.
To obtain a Licence from the Medicines and Healthcare Products Regulatory Agency (MHRA), it was essential for the Royal Liverpool Hospital to ensure that the new Aseptic Cleanroom Suite met the highest industry standards for quality and patient safety. This demanded a comprehensive validation exercise to confirm the integrity of the entire cleanroom suite, the performance of critical equipment, the suitability of procedures and strict adherence to regulatory guidelines.
Project scope
As an industry-leading provider of validation consultancy and testing services for contamination-controlled environments, Validair was engaged to undertake the critical validation exercise. The Validair team was led by Stephen Ward. The team worked in collaboration with the end users, Isolator Technology experts Envair, and enzyme indicator specialists Protak Scientific, to deliver a streamlined and efficient validation process.
Validation process
Stephen Ward explains the key steps in the validation process:
1. Initial Assessment and Planning.
We conducted a thorough risk-based assessment of the Aseptic Cleanroom Suite and identified the specific requirements for validation. We then expressed these in the User Requirements Specifications and Validation Master Plan. The design was developed and reviewed to ensure that key specifications, performance criteria and regulatory guidelines could be met. We completed the assessment phase with a formal documented Design Qualification (DQ). Our team prepared and then implemented a detailed validation programme.
2. Protocol Development.
Based on our assessment and design reviews, we developed detailed validation protocols which we tailored to the unique functionalities and requirements of the Aseptic Cleanroom Suite. These protocols outlined the specific tests, acceptance criteria, sampling plans, and test procedures to be followed during the validation exercise.
3. Installation Qualification (IQ).
The IQ phase focused on confirming the correct installation of the Cleanroom Suite. We ensured that all facility and HVAC components were correctly installed, calibrated, met the manufacturer’s specifications and adhered to regulatory guidelines. A review of validation packages confirmed the compliance of the isolators and the environmental monitoring system.
4. Operational Qualification (OQ).
During the OQ phase, our Validair experts thoroughly evaluated the operational performance of the Aseptic Cleanroom Suite. This was meticulous work that included testing all critical parameters, such as temperature and humidity control, air supply flow rates, room pressure differentials, filtration efficiency, recovery capability, airflow movement and airborne cleanliness. In addition, the function and performance of the monitoring and alarm system was demonstrated to conclude that it met expectations. Where we uncovered any deviation from the defined acceptance criteria, the source of the deviation was identified, formally documented and rectified.
5. Performance Qualification (PQ).
The PQ phase focused on validating the ability of the Aseptic Cleanroom Suite to consistently produce sterile products by mimicking real-life production conditions. The end users simulated operational activities, performed media fill trials and other operations.
This challenged the capabilities of the cleanroom suite through rigorous environmental and microbiological testing. We compared the results against predetermined acceptance criteria to ensure full compliance with regulatory standards.
The rapid gassing technology and the cycle development utilised enzyme indicator technology to validate the VHP decontamination systems that are integrated into every isolator.
6. Final Report and MHRA Submission.
Following the successful completion of our validation exercise, we compiled a comprehensive final report that documented all the tests conducted, results obtained, deviations identified, and corrective actions taken. Like all Validair reports, this pivotal evidence document also included a detailed summary of the overall performance of the validation exercise to unequivocally establish that the Royal Liverpool Aseptic Cleanroom Suite met all relevant regulatory requirements. In addition, the Validair team assisted in preparing and submitting the final validation package to the MHRA to obtain the Manufacturer’s Licence.
The Result
Thanks to the proficient collaboration between the Validair team, Envair, Protak, and the end users, the validation exercise for the new Aseptic Cleanroom Suite at Royal Liverpool Hospital was completed successfully. The cleanroom suite demonstrated its adherence to the highest quality and safety standards, which led to the MHRA granting the Manufacturing Licence in the spring of 2023. This achievement ensured that the hospital could provide safe and efficacious pharmaceutical products to its patients.
The validation of the Aseptic Cleanroom Suite at Royal Liverpool Hospital highlights the critical role played by Validair in ensuring compliance with regulatory guidelines and obtaining the necessary accreditation. The cutting- edge Isolator Technology deployed in the cleanroom suite, which includes rapid gassing, further enhances the hospital’s ability to produce sterile pharmaceutical products efficiently and safely.
