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Pharmaceutical Manufacturing and Packing Sourcer

Do It Your Way

When dealing with cold chain shipments, companies should always use packaging that has been properly tested or qualified for maintaining the necessary temperature range during the unique requirements of their transport lanes. After all, the main priority is to ensure product safety during transport, while also minimising the cost and environmental impact.

An organisation may choose between an off-the-shelf (OTS) option or a bespoke system tailored to meet their specific temperature range. The decision as to which to select largely depends on the parameters of their shipping environment, the value of the product, its thermal sensitivity, the implementation timescale and, of course, the company's budget. Whatever the choice, there are pros and cons to each route.

Fit for Purpose

Designed to meet each customer’s individual transport requirements, bespoke systems should fit in exactly with the organisation's operations. OTS products are designed to cover a range of specifications and shipping conditions, and vendors typically have a selection of sizes and service durations on offer.

Bespoke packaging will be tested and qualified to a specific application, whereas OTS options offer a broad level of performance data, rather than one dedicated application. The customer therefore needs to determine whether the package performance offered will be fit for purpose.

Optimisation

The number of packaging elements and their configuration are refined in a bespoke system. OTS packaging, on the other hand, typically uses standard modular components, often as part of a family product range. The payload can be optimised with a personalised solution – for example, operating and freight costs can be minimised – while the sizes of OTS products are generally larger than the customer would need. Similarly, going bespoke means that performance can be optimised, but for an OTS option, the packaging can often be slightly overengineered for the specific application.

High Cost

The total packaging cost is adjusted to meet the customer’s individual purpose when designing a unique system; however, the resourcing of the design and qualification project is high. For OTS products, the cost of packaging development is absorbed by the vendor.

One of the downsides to bespoke package design is the time that is required to develop the solution, and project lead times can be lengthy. With OTS ranges, performance data is available immediately and is easily accessible, resulting in a shorter lead time to implement the solution.

Key Factors

In an ideal scenario, every packaging user would operate a bespoke system, were it not for three important preventative factors:
  • Cost of design
  • Time for development
  • Need for an accurate and clearly defined brief 

Total Cost of Ownership
The cost to execute a bespoke project is high, due to the initial outlay in R&D resources, as well as the manpower needed to create and test prototype systems. There is also the possibility that new tooling could be needed to produce the system if existing tooling does not fit to the required dimensions, and costs can quickly add up. However, in the long term, the ongoing cost of a bespoke system should be lower than an OTS alternative, as the design and performance are optimised to meet the specific operation; therefore, there is a lower risk of temperature excursions.

When making their packaging selection, customers need not only to think of the cost per unit of the final packaging system, but also to look at the total cost of ownership (TCO) model. This is a financial calculation designed to illustrate the complete cost of a shipping solution, considering all direct and indirect expenses over its useful life. Rather than just focusing on the initial purchase price, TCO looks at the overall picture – from purchase through to disposal – in order to make an informed decision about the cost-effectiveness of a solution. The various cost elements include design, purchase, delivery, storage, assembly and forwarding expenses.

Time to Implementation

Historically, the time taken to develop a bespoke solution is much longer than for OTC products. The customer usually has a wish list of features to include within the system to suit their operations, as well as requiring it to accommodate their specific product. One particularly high demand is for the packaging to be adaptable and capable when encountering certain shipping conditions, such as during thermal and physical tests.

These requirements will need to be considered during the design stage and qualified using test chambers to ensure the quality is not compromised. During this period, there can be numerous models and test runs performed prior to proposing the final design to the customer. Subject to their approval, the vendor will carry out an operational qualification cycle test before submitting the result and reporting back to the customer. Overall, bespoke package development lead time can take many months to execute.

Effective Brief
The success of any packaging system can be determined by the accuracy of the brief originally set out by the customer. If the requirements have not been properly specified, then the packaging is unlikely to fulfil the product’s real needs.

To help avoid this error, customers must have a clear understanding of their transport lane logistics, as well as the needs of the packaging system during shipping. The vendor will usually provide support, and will work with the customer to ensure the specification is accurate and meets all the requirements of the operation process. This can also serve to reveal further processes that may have been overlooked, but will ultimately improve the final packaging system.

Finding the Balance

The real challenge that lies ahead for packaging designers is how to combine the two approaches to capitalise on the strength of each and eliminate their weaknesses. In essence, it will come down to the customer’s business needs, budget and how quickly the solution is required. Although bespoke options can prove particularly effective for a company, customers may be able to purchase an OTS solution based on an acceptable match between their requirements and the common functionality and procedures provided.

As new technologies advance and new materials are adopted into packaging design, the decision should come down to justification of the TCO for the packaging system selected.


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Jonathan Yap serves as the global Qualification Manager for Laminar Medica. He has led and been involved in various different projects for the world’s leading pharmaceutical, clinical trials and biotech corporations. He also has previous experience in polymer processing and packaging within both the construction and consumer product sectors. Jonathan holds a degree in Materials Science and an MSc in Manufacturing Engineering Systems.


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