Driving Temperature Profiling Productivity

Since 1996, Kneat’s solution partner, Pharmaceutical Calibrations & Instrumentation LLC. (PCI) has provided the Life Science Industry with high-quality equipment and instrument services including Validation, Calibration (Process Equipment Services, Analytical Laboratory Instrument Services, Metrology Services) and Commissioning.

Introduction & Background:

Transforming validation productivity 

Temperature Profiling is a standard validation requirement for GMP chambers used to ensure a temperature-controlled environment for in-process materials, equipment, raw materials, and samples. Even though the temperature profiling work process is well established, documentation activities comprising the process are inefficient, costly and paper-based.

This case study describes the development and digitization of an innovative validation process by PCI for their customers, leveraging Kneat’s paperless validation software to deliver a lean, end-to-end digital and compliant work process.

Challenge & Need:

Improved efficiency for partner customers

PCI’s goal was to minimize labor hours required to perform the CQV documentation activities required in temperature profiling, and as a result reduce cost – all while maintaining the same high level of service to it’s customers. Life Science Industry regulations require the Commissioning, Qualification, and Validation (CQV) of facilities and equipment involved in the manufacturing and processing of Life Sciences end products and raw materials. Regulated equipment commonly includes temperature controlled chambers, such as sterilizers, ovens, incubators, freezers and storage rooms; for which a prominent CQV requirement is ‘Temperature Profiling.’ Temperature Profiling assures that a temperature-controlled environment is maintained to support the manufacturing process. Technology solutions for collecting temperature data, such as data loggers, provide an efficient means of monitoring and recording temperature data at key locations within chambers.

However, the CQV documentation activities associated with temperature profiling (including protocol/test process steps, capturing results, pre and post-review/approval and final summary report generation) are conducted manually on paper. In this paper-based environment, accessing and interpreting key validation data, such as validation status and test results, is inhibited by the need to physically store, retrieve and examine paper records – activities which resulted in high labor hours and subsequent cost for PCI and it’s customers.

Solution & Implementation:

A digitized, standardized lean work process

PCI set out to achieve their goal of reducing the labor hours involved in temperature profiling, in two key stages. The first, was to create a best practice, lean work process, before secondly embedding this process into a software system capable of standardizing the process across PCI’s customer base.

After developing a leaner, optimized temperature profiling work process, PCI were able to determine detailed requirements for validation software and begin evaluating software solutions. The PCI team reviewed several commercially available systems, before selecting Kneat for its ease of use, robustness, flexibility to accommodate any GxP process and scalability.

Following their newly developed work process, PCI was able to create standard approved document templates that are auto-populated with system metadata and shared document data, all within Kneat. This meant that documents could be created quickly and with a high degree of accuracy, which resulted in reduced review and approval and rework efforts.

Results

A 65% reduction in labor hours per chamber

Prior to implementing the new digitized work process, PCI created and tested the concept for one of their customers to provide evidence of cost and labor savings. The proof of concept showed an average savings of 15 labor hours per chamber, reducing the average labor hours per GMP chamber by 65%, from 26 hours to just 9 hours.