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Pharmaceutical Manufacturing and Packing Sourcer

Ready to Launch

Lene Blanke at Promens Medical Packaging points out the commercial safety in providing unique primary packaging that is fully documented and all set to go to market

No company that spent millions developing a new drug would wish to have the launch delayed because of problems with production, registration or quality in relation to a relatively inexpensive packaging system. Developing a drug takes many years and, in the final phases, getting the drug safely delivered to the patient also takes up time and effort. Depending on the type of medication and therapy needed, an adequate packaging solution must be found. It should offer a continuation of the clean, sterile, pristine environment where the drug is manufactured, and with planning and the right partner it could also offer added-value.

Primary packaging offers a self-contained environment, ready to be delivered safely to the place of therapy. During the shelf life of the product, the packaging must not interact or interfere with the drug, must not contaminate the product and, by the time the drug arrives with the patient, it must give a strong, clear message that states the type, strength and batch of the drug without indication of foul play or tampering. This sounds very simple and there are many systems on the market offering this service in various standard solutions and process equipment to match. But what do you do if you would like to stand out with a special solution that sets your product apart and gives you an edge in the market? Could you risk changing the accepted design and still make the deadline?

Developing customised packaging is a challenge, but could give unique features such as design, protection for your drug against the external environment and barrier properties against oxygen or UV light. In addition, this gives you the opportunity to build in safety measures such as extra controls, minimised handling and a lower risk of contamination, or simply the chance to personalise the packaging for your drug or medical device.

The way forward is to find a supplier with a strong background in customised packaging who has knowledge and experience with documentation and project management. Once a supplier has been selected, take time to build a team with representation from both organisations. New packaging solutions are often made by a packaging development team, but as these have to coordinate with marketing, production, quality and formula development, the best option is to have all departments represented in the team. Often, small details that are not clearly understood or agreed by all parties can end up costing a lot of money and time, and therefore this broad participation is vital. Decisions on project objectives, methods to follow up, the setup of deadlines and milestones, and agreement on methods of communication are essential in order to secure a smooth process.

STAGE ONE: PLAN

An open discussion between the partners is essential and should allow time for necessary clarification steps. In the early stages there is a need to get a solution on the table, as we need to see a sketch and to look at a rendered 3D or full scale model. The model is only a suggestion, and a final solution can only be made after a clarification of all points and the agreement of all parties. Therefore it is essential to specify the details in the early stages, including material, method of sterilisation and production, but also which requirements from standards and pharmacopoeias should be met by the proposed packaging. It might sound easy and straightforward, but getting this right saves time and money. In addition, it secures the best foundation for the project team’s work.

It is often of vital importance to state quality requirements at this time. By designing a product and a production line properly, most of the risks can be handled, and sometimes even avoided, by being open about them at this stage. If new demands are added at a later date, decisions that have already been made could block the effective prevention of risks related to these new demands. This could make added controls necessary, which in the end could mean additional cost.

STAGE TWO: DO

As the development starts, it is important to look seriously at the possibility of using standard products for testing. For injection and infusion fluids this means that standard packaging solutions with similar wet surface and headspace volume will already have been made in the exact chosen material or combination of materials. Tests can also be performed at a later stage as samples can be made from test tooling equipment. Samples should be subject to different tests to assist in the final selection of material, and a stability test can be performed using the actual drug, packaging design and material. However this all depends on the timeline.

As the more creative part of the process starts it is important to involve both engineers and marketing staff. Allow for new ideas and display these in 3D, rendering surfaces and making mock-up samples of the product as part of the process. Again, open discussions are important – do not only speak about solutions but also agree to discuss issues such as design limitation and possible quality issues. Engineers must always keep the quality requirements in mind during this process as the end target must be sustained. Any decisions made earlier that collide with the specification requirements must be addressed by the parties involved in order to allow for risk assessment and evaluation.

STAGE THREE: STUDY

As the project group works together, the real benefits of open group cooperation starts to show. If the project is on time and products start to work on the production line, in turn achieving the right output without problems, the team’s work can be classed a success. If, however, by lack of cooperation misunderstanding has crept in, such as dents on the final container, scratch marks on the shoulder of a bottle, a lack of production capacity or problems with the overall cost of the product, the team could clearly have performed better.

Therefore, take time to let the team meet after finalisation to make an evaluation. This is an important step which is often overlooked as we quickly move on to new projects and other issues. However, allowing time to evaluate and reflect gives the team the opportunity to discuss what went well and what could have been done better. This new knowledge is taken away by each team member as he or she moves on to the next project.

STAGE FOUR: ACT

Based on this knowledge, both companies can now go back and reflect on which changes should be made in their organisation before the next project. Often, the building of the team, and the sharing of information during the planning phase can never be underestimated. An hour spent on this part of the process improves future work and saves time in establishing that the next project runs smoothly.

CONCLUSION

There are many methods that can be employed, all depending on the terms of the agreement, the demands and the work that companies carry out together to make a customised packaging solution. ‘Plan, do, study, act’ is the cycle to learn from, and in a structured methodology, it will improve systems and accommodate expectations for a product without problems. By implementing this method fully a system can always be improved. Every stage in the process will bring you steady improvements, moving you towards a perfect model. The involvement of pharmaceutical and packaging companies in such a common project, and their inclusion in the development of a final product that truly works, means a great deal of trust must be put in a partner. Nevertheless, the end result is worth the effort, offering unique product advantages to the medical professionals and the patients using it.


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Lene Blanke is head of the Development Department at Promens Medical Packaging A/S in Langeskov, Denmark. She holds a BSc in Mechanical Engineering and an MSc in Business Economics, and has considerable experience in development and cooperation with customers in product development projects. In June 2010 her production team received an MDEA award for an innovative transfer device, developed in conjunction with Danish Hospital Pharmacies in AMGROS.
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