By CurTec International
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CurTec warns of perils of ‘simple’ packaging changes
Rijen, Netherlands: – A specialty manufacturer of high-performance containers for the pharma and chemicals industries has warned manufacturers that seemingly trivial isolated changes to primary packaging specifications can have ruinous consequences.
Dutch-based CurTec International says that a single small change to a container specification can undermine the registration and regulatory approval on which the entire marketing process is based – as well as raising serious issues like Health & Safety.
The end result could be that a change intended to save hundreds of dollars could ultimately cost many thousands or even millions in lost marketing approval.
QbD: Quality by Design
To combat the danger, CurTec has embraced Quality by Design (QbD) disciplines as well as offering clients a single audit procedure to check that revised packaging is still fit for purpose.
Three QbD experts working with CurTec, By Kin Chun Cheung, Dominiek Rossillion and John Nuyens, have just shared their conclusions in the company’s latest blog.
“Pharmaceutical products require registration – the process of acquiring approval to introduce them into a specific market. It is a detailed summary containing extensive information that includes the packaging format and other relevant product specifications,” the authors point out.
“When looking in detail at the packaging section of a registration file, every pharmaceutical product bought at a pharmacy is registered in the format in which it is delivered: from the cardboard box and its print to the plastic type and shape of the primary packaging. When it comes to registration, packaging and its design are dynamic. Changes to the container may influence important tests, such as stability, shelf life and other factors,” they warn.
Other elements besides legislation can come into play when making a packaging change. To illustrate this, Kin, Rossillion and Nuyens construct a fictional case study of a sterile active pharmaceutical ingredient (API) manufacturer seeking to reduce transport and handling costs by changing batch packaging from 100 one kilo containers to ten 10Kg drums.
“That API is registered, which means that changing packaging will lead to changing the registration file. If the registration file is included in the registration file of the final product (e.g. the lot sizes of raw material), that document will also have to be modified,” the authors point out.
“Another chapter of the registration file concerns stability testing: usually a representative sample is required for stability testing. In most cases a number of containers are kept aside annually for representative stability testing. With the new container, 10 kg would be a significant product loss while a smaller sample size might not be accepted as representative,” they write.
“Change of dimensions and capacity can also influence the way a product is shipped and how it can be impacted during transport, intermediate storage or handling. All steps in the process will need to re-consider. Where the process involves a lot of manual handling, new carts may be needed along with new procedures.”
Health and Safety issues
“What about Health & Safety or ergonomics? Lifting one kilo is considered safe and will not cause injury, but lifting 10 kg from the ground to processing height is not a sustainable solution for routine operations. Now our formulation area will need a mechanical lift made of pharmaceutical grade stainless steel, which will increase the budget. A similar lift is needed in the processing area, where sterile conditions apply. And then there is the question whether the current installation can accommodate new tools,” say the QbD experts.
The authors argue that a simple primary packaging change can thus have “a severe influence” on all aspects of the production process and requires thorough analysis.
“To avoid high unexpected project costs, a multi-disciplinary impact assessment has to be performed on the product flow during the concept phase in which a packaging developer or manufacturer should be involved in the earliest possible stage,” they add.
CurTec has recognized that its pharmaceuticals and fine chemicals customers live in an increasingly complex world by introducing a Packaging Scan audit service.
The CurTec Packaging Scan is a two hour multi-disciplinary session that can review every relevant aspect of a client’s packaging requirements and advise them on the most suitable solution.
The scan focuses on optimal protection of product, brand image and communication, compliance and legislation, packaging and logistics requirements, handling issues, environmental aspects, hidden costs and added value.
The free report can provide CurTec customers with peace of mind that a proposed packaging change intended to reduce cost will not have the exact opposite result.
About CurTec International
CurTec International is a specialist manufacturer of high performance plastic packaging optimised for the needs of industries like pharmaceuticals and fine chemicals where hygiene, moisture control, UV protection, hazmat compliance, barrier control and tamper-proof security are critical factors.
The privately owned Netherlands-based company develops, manufactures and distributes a range of niche-designed drums and crates that add value through quality, user-friendliness, security and reusability. Today CurTec drums and containers are widely used throughout the pharma and fine chemicals industries for shipping and storing fine chemicals, APIs and intermediates as well as finished powder, tablet and paste products.
The company maintains a quality assurance program that includes HACCP and ISO certification and a Drug Master File for all packaging products.
CurTec adds value to the supply chain of companies producing active ingredients, excipients, solid dosage forms such as tablets and capsules and specialty chemicals. It not only supplies off-the-shelf packaging but also designs customized packaging solutions to meet the needs of individual clients.
Tel: +31 88 808 2052
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