Selection guidance of an Aluminum Seal cap provider

As a professional in the pharmaceutical market, you may need to select and source Aluminum Seal crimp caps to effectively seal vials and protect your formula (vaccine, serum, vitamins) from external aggression (germs, oxygen, pollution).  Aluminum seal caps are a crucial part of a vial system. The selection of an appropriate seal supplier is critical.
In this article you will find major guidelines to ease, secure and strengthen your supplier selection process.

What is a pharmaceutical aluminum seal crimp cap ?

A packaging assembly component :

Most of the time, the vial sealing solution contains a rubber stopper (butyle or silicone) and an aluminum-based crimp cap to ensure the integrity of the vial. This aluminum overseal may include as well an assembled plastic lid, which protects the injection site of the rubber stopper and which will be removed by the nurse or physician who administers the drug. The different colors of the plastic lid ensure drug-recognition on the shelf and reduce administration errors. The aluminum material comes as a coil in the relevant color shade while the rubber plug and the plastic cap are delivered in boxes also in the agreed color.
The foil, the rubber plug and the plastic cap goes through the incoming quality test control before getting the green light to move to further manufacturing steps.

Aluminum Seal cap manufacturing process :

The aluminum coil is then unwound under the press, cutted and embossed and formed according to the customer's specifications.  In process quality control are operated to make sure the production is in specification and can go to the assembly process. In some cases other manufacturing steps may come into play such as lubrication, cutting, embossment, cleaning, sterilising.   

Assembly process :

In some cases the flip off plastic cap is the third component which comes into play.
The metal shell and the two or three parts are assembled together under a strict index or continuous motion assembly process. Optimal online checks are made including 100% visual control of the assembled products, in terms of functional, dimensional, cosmetic and aesthetic compliance.

Aluminum Seal cap shipping conditions and specific asepsis constraints :

In some cases, the cap supplier is asked to secure the packing and shipping under a sterilized environment. In this case, the caps are packed in a sealed bag filled in a clean room or at least in a controlled air flow.

Aluminum Seal pharma cap market panorama

The aluminum seal cap market for the pharmaceutical industry is estimated at least at 15 Billion of caps supplied by less than 2 hands full of manufacturers around the globe.  Within this small group, only few qualify for the highest market standards required to supply the major global pharmaceutical firms.
Therefore, if you are seeking for the best packaging to protect your product, secure your sourcing, ease your filling for an overall benefit of your brand image and profitability, you need to select from these premium quality players.    

Which are the mandatory steps to select a new source for aluminum seal caps ?

You most probably already follow an internal selection protocol. Nevertheless, here are some guidelines you may consider in order to check that your selection process is properly matching and overlapping our recommendations. Here are some questions you and the other stakeholders may want to answer upfront :

Do you need to source a “me too” product ?

Sourcing an exact “me too” aluminum seal cap is usually required as your products are filled and must follow a strict protocol (such as FAD).  Therefore, these are the technical aspects you shall consider to validate the exact similarity :

• All dimensional and ethical elements in depth making sure the tolerances are identical
  
• Manufacturing processes should be as close as possible and specifically in terms of production environment (ISO class room)
• If storage and shipping will obviously change from one production location to another, we recommend you proceed with storage and shipping test at various season in order to make sure they don’t impact the finish product
• Finally, documentation will need to be as close as possible in order to avoid additional workload and reduce the risk of error.

Looking for an aluminum seal cap supplier with new or different characteristics ?

Manufacturing quality standards are probably the first aspects you may want to address.  Within the premium short list of suppliers, the highest quality standards are a must and should be a given for their clients.

• Supplier qualification process and incoming raw material inspection have a strong impact on the finished packaging component and should be scrutinised before starting any product qualification testing protocol.
  
• Standard services offered by the cap supplier are to be evaluated as they are provided with no additional cost. In addition, we do recommend you get a clear and detailed scope of the extra services you may need within the course of the contract life.

How should your next Aluminun Seal cap provider help in the process ?

• As an example, at EMA Pharmaceuticals, we have a specific “onboarding” protocol for new customers putting a special emphasis on easing and smoothing all your qualification process.  
• Indeed, if you provide your expectations and we mirror them, harmonising our documentations and processes to minimise your workload and our impact within your supplier portfolio.
  

To conclude :

Unfortunately, recent sanitary and geopolitical history has proven that duplicating packaging components sourcing capabilities is worth considering to secure your market supply, your customer and your shareholders revenues. We know how complex it is to change a supplier portfolio within the pharmaceutical industry specially for drugs subject to prescription. We do recommend you challenge your next potential aluminum seal cap supplier to make sure you don’t miss a profitable opportunity.