The importance of temperature monitoring device maintenance and health checks
The intricacies of autoclave validation are acknowledged industry-wide within the pharmaceutical realm. Sourcing dependable equipment that adheres to stringent GMP requirements, which involve meticulous data collection and documentation of performance, can make the FDA approval process a rigorous undertaking.
For more than six decades, however, KAYE instruments have been at the forefront of thermal validation for the pharmaceutical market.
Thermal Validation in Pharmaceuticals
Did you know that over one billion prescription items were dispensed in England alone between 2022 and 2023? With such a substantial demand for pharmaceutical manufacture, it's not hard to imagine the vast array of firmly established GMP protocols and regulatory guidelines that large-scale pharmaceutical companies must follow to distribute product.
Thermal validation is one of the many crucial quality assurance processes within the pharmaceutical development landscape. Employed to verify and document the effectiveness of any process that must meet specific temperature-related requirements to a regulatory standard.
Such critical processes are seen in an array of applications, including:
- Steam Sterilisers
- Dry Heat Sterilisers
- Steam in Place (SIP)
- Water Cascade/Fall Sterilisers
- Incubators
- Stability Chambers
- Freezers
- Freeze Dryer/Lyophilisation
- Vessels
Thermal validation assumes a pivotal role in the sterilisation of pharmaceutical goods and the manufacturing or testing of products. Autoclave validation provides the necessary documented evidence and regular data collection critical for maintaining a traceable regulatory pathway of sterile instrumentation.
Challenges within autoclave validation
Autoclave validation presents itself as one of the most stringent thermal validation processes, one that pharmaceutical manufacturers and biotechnology research organisations know all too well. For this reason, the complex process requires specific attention to several factors:
Data accuracy and integrity
For an autoclave to be correctly validated, data accuracy throughout the process is paramount. Essential requirements of data include regular instrument calibration, proper sensor placement, as well as accurate collection and transmission of all necessary data, from temperature to process protocols.
Maintaining data integrity is essential for FDA, MHRA and many other compliance bodies, the challenges arising from these demands lies in the accuracy and traceability of all collected data.
Documentation
Regulatory standards require detailed documentation and record-keeping. It is not enough for the data to be harvested, but it also needs to be maintained for any regulatory auditing. The challenge in maintaining comprehensive, highly accurate reporting is that it can be a time-consuming process.
Nevertheless, long term data keeping is necessary for true evidence of compliance. This includes IQ, OQ and PQ protocols to cover documented proof of correct equipment installation, consistent autoclave performance under operational conditions and ongoing correct maintenance.
Identifying a data logger
By nature, the autoclave operates under copious amounts of pressure and steam, this poses a challenging atmosphere for a standard data logger to perform sufficiently. Many on-the-market data loggers aren’t specifically manufactured to work under the hostile parameters found in an autoclave, but instead more suitable for temperature monitoring applications such as storage units.
Stakeholders, laboratory managers and compliance QC personnel must do their research when looking for the right temperature logger that can accommodate the unique specifics of autoclave validation, often entailing more sophisticated and robust technology.
Regulatory compliance and autoclave validation
Regulatory compliance within autoclave validation involves standards set by Good Manufacturing Practices (GMP) and primarily govern the UK, US and EU.
The FDA and MHRA are two examples of regulatory agencies employed to ensure compliance to GMP, as well as pharmacopeial standards and ISO standards, throughout the validation process. This includes the assessment of meticulous documentation, record keeping and data integrity requirements.
As we’ve detailed, the protection and collection of electronic data records and their handling, with regulatory guidelines such as the FDA 21 CFR PART 11 setting stringent standards for all electronic records. This covers:
- Data integrity: All electronic data must be protected and securely managed
- Traceability: All electronic records including protocols and reports must be stored, archived and retrievable for the necessary retention period
- Auditable data: Systems must generate secure, computer-generated, time-stamped audit trails to document actions and events
Specifically for autoclave validation, electronic record-keeping must also accurately capture and represent the steps taken to achieve and maintain sterility. It’s here that the complexity of autoclave validation data can make the regulatory process tricky.
Autoclave validation in particular generates various strains of complex data such as temperature profiles, pressure readings, minimum and maximum temperature readings and other parameters. Collecting, analysing, managing and accurately recording the data which represents these variable conditions, all through electronic means can be a challenge.
Paving the way with KAYE instruments
Validation systems have long played a key role in achieving and documenting compliance with high-scale pharmaceutical manufacturers, KAYE instruments has been at the forefront of the market since 1972 when the Kaye System 8000 transformed the existing landscape with an in-built data recorder.
The introduction of their products was sector changing. Kaye recognised the problem faced by many pharmaceutical organisations across the globe and crafted a solution entirely dedicated to those individuals who regularly conducted autoclave validation. It didn't take long before their products were being chosen, as the preferred choice for thermal validation regulatory compliance.
After firmly establishing themselves within the high-scale pharmaceutical market, the pioneering Kaye Validator 2000 V2K continued the historical effects from 1999 onwards. Now, in 2024, the same system has been a widely recognised and credited for the standard it has set within thermal processes for over two decades, creating a household name as an FDA-favoured validation commodity. This system has paved the way for many more Kaye products to enter the market and solve the bottlenecks of pharmaceutical manufacturing. The Kaye AVS is one of the most recent products on the market and lifts validation to a whole new level!
Why does pharma continue to choose Kaye for autoclave validation?
Designed to address current pharma market challenges surrounding complex data collection and management, KAYE technology is heavily intertwined with pharmaceutical compliance and regulatory approvals, so much so the systems evolved to create a reputation as instrumentation specifically deployed to ensure compliance with regulatory standards.
A crowd favourite due to its simplification of the notoriously time-consuming validation reporting process, the Kaye V2K reduces set-up time and minimises sensor handling. It also automates sensor calibration, neatly organises data and generates regulatory reports. Its robust nature means it can withstand the test of time, and the rugged environment that exists at the centre of a manufacturing plant, naturally making it the ideal solution for autoclave validation.
The major redesign of the first editions of Kaye validators still exists in many of the largest pharmaceutical plants in the world today, operating smoothly and streamlining compliance naturally.
Although Kaye pinpointed themselves as the ideal instrument for thermal validation FDA compliance, they did not stop there. Driven by the continuing dedication to answering the needs of the sector, in 2015 the successor to the Kaye V2K erupted the autoclave validation market.
Advancing their own technology, collating their expertise and knowledge as well as listening to their markets feedback, Kaye continues to be the obvious choice for compliance, whether it’s through the KAYE V2K or the Kaye Validator AVS.
The KAYE AVS Thermal Validation System
Introducing a new era of thermal validation, the Kaye AVS Thermal Validation System; a market-leading, advanced model that provides an entirely new upgraded validation concept.
Specifically developed to evolve alongside the stringent GMP standards and assure FDA approval, the AVS integrated system offers comprehensive documentation and reporting capabilities, including audit trials, rigorous data protection, secure file management and unauthorised access prevention technology.
The system offers:
- Highly accurate sensor measurements
- GMP requirements for calibration
- Fulfills traceability to national standards
- Generates compliant reports
- Manages the validated assets and validation equipment
The AVS system provides a simplified validation process that is both cost-effective and time efficient. Pharmaceutical stakeholders benefit from its intuitive, user-friendly software interface for the ultimate ease of use within a formerly challenging process, making it the preferred solution within a time-pressing industry.
We’re proud to have maintained a 30+ year relationship with KAYE Instruments. Withnell Sensors serves as a trusted supplier, providing expert advice and technical support surrounding the KAYE validation portfolio.
We’ve not only developed a unique rental system to accommodate ad hoc validation requirements, but we also provide unbiased expert advice on how to transform your autoclave validation processes using KAYE instruments, contact Withnell Sensors.
