While product integrity can be tightly managed in controlled manufacturing environments, storage and transport can expose materials to the dangers of damage and contamination. This article explores how a more considered approach to secondary packaging can help biopharma suppliers mitigate risk and increase confidence.

The biopharma sector devotes significant investment and innovation toward ensuring that its manufacturing environments are as efficient and controlled as possible.

This is essential to protect the integrity of solid input materials such as high-purity bioprocess chemicals, bioexcipients and dry culture media. However, beyond these manufacturing sites, products must navigate a global network of suppliers and specialist partners, which subjects them to a higher risk of handling damage or exposure.

Materials compromised during storage or transport may be rejected on receipt, disrupting the tight schedules of biopharma production and triggering lengthy investigations. In the case of many niche therapies and blockbuster products, costs as a result of delay could escalate as high as $600,000 and $8 million a day, respectively [1].

With global supply chains becoming increasingly complex, global biopharma suppliers must investigate more proactive ways to mitigate contamination, moisture ingress and handling risks. This is where a more prepared approach to secondary packaging selection can deliver real benefits. By rigorously selecting and testing the drums, pails and jars used for transport and storage, suppliers are able to engineer more predictable performance, supply chain continuity and audit confidence.

Designing out contamination risk
A key risk for biopharma input materials outside controlled manufacturing environments is the threat of contamination.

While this is mostly caused by physical handling and exposure to the elements, contamination can take several forms. Particulates from fiber-based drums and metal clamping rings can be jarred loose during handling and opening, contaminating otherwise clean materials. Frequent movement between the warehouse and the preparation areas raises the risk of transfer of external contaminants onto container surfaces. In addition, fiber drums are often hard to clean, meaning that bacteria and mold may be carried into controlled spaces.

It is possible to control these factors by selecting packaging systems designed to minimize contamination risk. These include the use of fully plastic packaging to eliminate fiber and metal contamination, and the use of smoother, non-porous high-density polyethylene (HDPE) surfaces, which are easier to clean. Shock-absorbing packaging reduces the risk of internal damage, while fully plastic screw-top closures ensure that packaging can be sealed more consistently.

Suppliers can also benefit from better traceability and reliability by producing HDPE packaging under good manufacturing practice (GMP) conditions.

Delivering more consistent moisture protection
Even the most limited exposure to moisture can have an impact on the flow properties and behaviour of a material. 

For many products – particularly moisture-sensitive powders such as buffer salts and culture media, tolerance for moisture deviation is essentially zero. This is compounded by the fact that many moisture-based issues are not discovered until receipt or preparation.

To mitigate the risks, products often need to be subjected to an additional handling sub-operation which breaks the material down before preparation. This adds time and complexity, and increases the risk of variability in production.

Suppliers can adopt measures such as installing screw-top plastic closures to maintain the integrity of the barrier during transport, opening and closure, as well as using integrated gaskets. Greater consistency can be achieved by manufacturing packaging under GMP conditions, and by compiling performance data to better understand and control barrier performance.

Protecting against stress and damage
As the sourcing needs of biopharma expand, materials are increasingly being shipped longer distances between local manufacturing operations in different regions. This increases the amount of handling by different partners and the risk of damage during transport.

For example, if solid input materials are shipped via air freight, they are exposed to factors such as vehicle vibration, as well as pressure changes that can cause containers to deform. If containers are stacked inefficiently, this can lead to uneven weight distribution and perhaps pallet collapse. 

Suppliers can manage this risk by standardizing secondary bulk packaging to reduce variation and ensure more even loading for transport. Developing packaging under GMP also helps to maintain structural integrity and consistency. Using packaging that is subjected to United Nations (UN) testing can verify its performance in specific load and stacking scenarios, giving all parties greater confidence that packaging can withstand conditions reliably as it progresses along the supply chain.

The value of preparation in secondary packaging control
As products move further from safe manufacturing environments, the level of control that suppliers can exert decreases. Therefore, it is essential that they go above and beyond to ensure that they take every measure to proactively manage against known threats at the outset.

Rejected shipments and delays can be costly. Therefore, choosing a secondary packaging partner that can demonstrate exceptional design capability, manufacturing discipline and consistent performance can pay dividends several times over. For example, while many input materials do not require UN Class X certification for their transport needs, a partner that meets these high transport requirements can provide a higher level of robustness and compliance during the handling process.

It is not an advisable strategy to wait until failures occur to address known issues in transport and handling. By taking a more proactive approach, companies can mitigate many of the risks upfront, and build a more sturdy reputation for quality, reliability and supply chain resilience.

References:

1. Roth, C. (2019, May 9). The real cost of clinical trials. Praxis Communications.https://www.gopraxis.com/news/the-real-cost-of-clinical-trials/

Head of Global Marketing & Intelligence at Netherlands-based CurTec, a provider of design, manufacture, and distribution of high-performance packaging for leading pharmaceutical, speciality chemicals, and food ingredients companies, John has been with the business for over seven years, helping it to deliver consistent growth in a highly competitive marketplace.