Optimizing Quality Control: Non-Destructive Weight Checks

Enhancing Drug Production Efficiency and Precision with the WMF Series Weigh Module

Berkshire Sterile Manufacturing (BSM) collaborated with METTLER TOLEDO to reduce product loss in their fill process. Through the integration of the WMF Series weigh module, BSM has seen significant improvements in its production metrics. Learn how BSM overcame its challenges and achieved success.

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Reducing Product Loss and Enabling Non-Destructive Weight Checks

BSM’s main challenge was to reduce product loss, considering the high cost and limited availability of the medicines produced. In December 2022, BSM had already validated a new fill process aimed at minimizing line losses and filter holdup to less than 30 mL. However, they recognized the need for an additional solution to enable non-destructive weight checks during filling. Incorporating an analytical balance into an isolator where drug product filling occurs presented several challenges. Various factors, including laminar flow and mechanical vibrations, need careful consideration due to their potential to yield inaccurate measurements. The 316L SS housing and FDA-approved gaskets work well with sanitizing vapor hydrogen peroxide (VHP) cycles ensuring a long product lifespan.

BSM and METTLER TOLEDO Identify Precision Scale Solution

To address these challenges, BSM and METTLER TOLEDO collaborated to identify a precise and durable scale suitable for their requirements. With its precision of 0.1 mg, the WMF utilizes advanced noise filtering to account for external influence factors that potentially affect accurate readings, such as vibrations or air currents. The fast format change with an easy-to-replace weighing platform allows BSM to quickly adjust to new samples or product types, minimizing downtime in their operations. Additionally, the weigh module's stainless-steel housing and the wash-down option module enable clean-in-place procedures, eliminating the need for disassembling the weigh module for cleaning. The WMF is equipped with mechanical interfaces designed for adapting to specific applications. BSM used these features to design and manufacture supporting structures that would securely hold the scale, mitigate mechanical vibrations within the isolator, and enhance the ease of use for operators.

By implementing the WMF, we now perform non-destructive weight checks, allowing those filled vials that would otherwise be consumed, to be used in clinical studies and to treat patients.
Process Engineering Manager from Berkshire Sterile Manufacturing

We interviewed the Process Engineering Manager from Berkshire Sterile Manufacturing to hear firsthand about the collaboration process:

What is the purpose of the WMF in your fill process and how has it improved your production metrics?

The Low-Loss Fill Process is a recently developed and validated process with the purpose of reducing drug product loss during filtration and filling for high-value and low-volume drug product lots. When the process was first developed, destructive weight checks were still being performed. This would consume filled drug products and add to the loss in the process. By implementing the WMF, we now perform non-destructive weight checks, allowing those filled vials that would otherwise be consumed, to be used in clinical studies and to treat patients. In a recent client fill, we were able to keep the total loss of product, from formulation and filtration through filling, to under 10 g. Non-destructive weight checks have been instrumental in achieving these low losses.

What was your experience integrating the WMF into the fill environment?

The METTLER TOLEDO team continues to be exceptionally helpful. We worked on every detail together from cabling options and the chassis support to software solutions using APW-Link. METTLER TOLEDO representatives from Europe and the US visited BSM to help set up filter characteristics appropriate for the mechanically noisy environment of a Grade A isolator space. The collaboration with Mettler has been productive and fruitful.

One WMF is installed to verify very fine doses of expensive materials. What specific features were of value?

The low cut-off frequencies of the WMF filters allowed us to perform accurate and repeatable readings even in our difficult environment. If the scale could not read accurately within the Grade A space of the isolator, then non-destructive weight checks would not be achievable.

By implementing this solution, BSM has been able to prove the efficacy of its low-loss process, which has historically been extremely challenging due to a weighing device’s contribution to measurement uncertainty. The WMF optimizes the typical tradeoff required between precision, speed, and cleaning ability.

Integrating Smart Sensors for Industrial Weighing

With rising costs, growing industrial skills gaps, and a need for measurable ROI, manufacturers are turning to automation and condition monitoring to increase performance and equipment uptime. The "Smart Sensors for Industrial Weighing" eBook delves into topics such as:

- IT/OT convergence

- Cumulative enhancements

- Condition monitoring

- Reducing complexity

- And selecting smart devices.

Furthermore, it provides tips on finding and selecting the best weighing technology for your needs.