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Anika Adams |
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Case study pharmalytics the compliant paperless lab. |
Pharmaceutical manufacturing is notorious for stringent documentation requirements — and many labs around the world still rely on paper records. However, transcription errors can cost companies in terms of regulatory fines and product recalls. One testing lab in Australia is all but eliminating data errors while enhancing throughput using Excellence instruments, LabX™ software, and fewer employees.
Meet Pharmalytics
Pharmalytics is a GMP contract testing service provider catering to the pharmaceutical, life sciences, clinical trial, and veterinary sectors founded by Dr. Russell Kinghorn. Dr. Kinghorn aimed to create Australia’s first and only pharmaceutical testing laboratory with a paperless quality management system based on comprehensive electronic data integrity (Figures 1 and 2).
To achieve this feat, Dr. Kinghorn set about creating a lab that would:
- Rely on a limited number of instrument manufacturers. His goal: To limit required user training.
- Be easy to manage. His goal: To find a suitable software system that would support as many analytical processes as possible.
- Make compliance easier. His thinking: A limited number of manufacturers plus comprehensive software would simplify validation and compliance.
You can read about his experience, hurdles, and successes in this case study.
In the end, Dr. Kinghorn chose METTLER TOLEDO as one of only two manufacturers to make it to the laboratory’s benches for three reasons: “Their instruments are second to none. All analytical instruments build one network using the same software platform. And as all components are built to adhere to regulatory requirements, I can create a compliant network.”
“We have almost eliminated all paper from the laboratory,” Dr. Kinghorn adds. Additionally, he appreciates that if a lab team member knows how to work with one analytical instrument by METTLER TOLEDO, they can work with all of them. This cuts down not only on training time but also error potential.
Compliance: Easy and Efficient
Pharmalytics covers a significant portion of its IT landscape with LabX as its instrument-integration software. With it, Dr. Kinghorn connects various analytical instruments including titrators, pH meters, analytical balances, and spectrophotometers. Additionally, LabX seamlessly communicates with the laboratory’s LIMS. Of his decision to use LabX, Dr. Kinghorn says, “We have only one platform to validate, train people on, and so on.”
Dr. Kinghorn can only run his near-paperless laboratory if all connected instruments and processes are capable of complying with regulatory authorities. Because of the inherent “connectability” of METTLER TOLEDO instruments, his life is made easier. Consider the following scenario as a concrete example of what Dr. Kinghorn is developing across his lab.
UV/Vis: A Convincing Example
The UV7 (Figure 3) is the smallest pharmacopeia-compliant spectrophotometer on the market, which caught the attention of the lab team. This, plus the easy record-keeping enabled by LabX and automatic pharmacopeia qualification via CertiRef™, tipped the scales. The unique CertiRef module includes NIST-traceable, certified reference materials. All nominal data required for evaluation is electronically stored, automatically matched with test results, and securely documented. Errors from user calculations and manual data entry from certificates are eliminated.
Dr. Kinghorn remembers that in the past, it took an entire day to mix up all the solutions and do the testing required for spectrophotometer qualification and validation. Now, CertiRef is mounted on top of the UV7, and the software works its way through required tests and creates a digital report. “Now, with CertiRef, the process takes just an hour and a half,” Dr. Kinghorn notes.
Triple the Workload, Fewer Employees
Pharmalytics typically analyzes raw materials, active pharmaceutical ingredients (APIs), finished products, and assays for phase 1 and 2 clinical trials. Typically, employees run methods just a few times rather than setting up long runs of dozens of samples. Instruments like the METTLER TOLEDO UV7, which offers a series of ready-to-use methods, are quite helpful to Dr. Kinghorn’s team.
Dr. Kinghorn recalls a recent job his team completed using the UV7. “It was a clinical trial that required a protein-content assay. In LabX, we found an appropriate protein-content measurement; the team imported it and adapted the name and calculations to the customer’s requirements. We were able to save the method and validate it quickly.” Then the UV7 did its work, quickly, accurately, and in a way that enabled excellent compliance.
Pharmalytics employees are still responsible for sample preparation and analysis. However, integrating the instruments into the network eliminates individual entries as data is transferred automatically. Furthermore, manual documentation efforts are no longer necessary. This setup enables Pharmalytics to handle triple the workload with only ten employees.
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Figure 1. Pharmalytics founder Dr. Russell Kinghorn set up the whole laboratory from scratch to be the first true lean pharmaceutical laboratory in Australia. |
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Figure 2. Life as the head of a GMP laboratory can be easy — if all instruments and processes can comply with regulations. |
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Figure 3. The UV7 is the smallest spectrophotometer that can achieve pharmacopeia compliance on the market. |
Manual is Now the Exception
Even though some legwork is still required, Dr. Kinghorn says the efficiency of individual measurement tasks when enabled by smart, networked instrumentation is increased by more than 150% compared to manual analyses. Dr. Kinghorn is quite specific in his efficiency estimates, as he previously started and sold another contract laboratory with nearly 50 employees before starting Pharmalytics.
The entire laboratory is as close to paperless as it gets. Savings are achieved in areas such as maintenance, validation, and personnel. The most significant effort comes from the detailed setup of instruments and software. However, once this is done, the result is more than worth it!
Make the Switch
Even transitioning a single workflow from manual to paperless can save a lab time and effort in the long run, but Dr. Kinghorn feels the most significant savings come from transitioning an entire lab from paper to paper-free. If you can manage the space and have the budget, he also has a suggestion for how to do it most efficiently: “Buy your new equipment and set it up alongside your existing equipment to allow sufficient time to make sure your upgraded workflows are compliant, validated, and operational. Then, once any issues have been resolved and the new system is ready, make the switch.”
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