Flip-Off cap sourcing: best practices for the pharma industry

The sourcing of pharmaceutical packaging components such as aluminum overseals for injection vials, also commonly called Push-Off crimps or Flip-off caps, can really be jeopardized by multiple global geopolitical and sanitary events. If you are in charge of procurement, sourcing, production or even quality of a pharmaceutical filling site, you may want to investigate how you could reduce and even offset the risk of supply of crimp caps while remaining in the highest quality standards.

Which are the risks the pharmaceutical industry is facing in regards to Flip-Off cap ?

The Flip-Off cap, an essential element for the pharmaceutical industry

As a professional in the field of healthcare, you are concerned about providing your valuable and often life-saving drugs timely and in sufficient quantities to the patient. The use of proper packaging materials to protect your product over the supply chain and during its whole shelflife is crucial. Aluminum-based overseals are considered as part of the primary packaging components for your drug, at the same level as the container itself (glass or plastic vial) and the butyle rubber stopper. Even if technically the aluminum crimp cap is not in direct contact with the product, it is a crucial part of the sealing solution, ensuring the integrity of the filled vial. Whatever vial sealing solution you are using and sourcing; these are the major risks you could potentially face :

Risk of an “out of stock” (OOS)

Sure, you’re holding a security stock. But are you sure that your supplier of aluminum crimps or Flip-Off/ Push-Off overseals can supply you on time to ensure the execution of your production plan.

Risk to have to choose a fall-back option under market pressure

You certainly do not want to compromise on the quality of the primary packaging materials for your valuable injectable drug.

Risk of regulatory impact

As for the type of glass and the type of rubber you’re using, the type of overseal is also specified in the registration file of your drug. You therefore might consider the anticipation, together with your QA- or Regulatory-team, of the regulatory impact of the use of crimp caps from alternate suppliers.

Risk of not having the human or finance resources to qualify a suitable alternate supplier of Flip-off caps or aluminum overseals

How do you ensure that the alternate supplier is manufacturing the overseals under GMP conditions? Especially if you’re sourcing the Push-Off/ flip-Off overseals RTU - ready-to-use inside your sterile filling environment? Regulatory-wise, the ISO- and GMP certificates of the alternate overseal-source may not be sufficient and the agenda of your QA-team for a proper audit of the Flip-Off cap supplier, might not suit the imperatives of your production agenda...

Which are the consequences of not being able to source on time ?

Risk of not being able to supply upon market demand

Your fill & finish-team and equipment is ready, the formulation bulkware as well, nevertheless without the suitable primary packaging components, vials - stoppers and crimp caps/ overseals - nothing will happen, …except a huge financial loss !

Losing not only market shares but market faith

You might have read or heard it a thousand times already; it takes ages to build confidence - but only a one-time mishap to shatter it down to nothing. More than ever, the reliability of your supply chain, including the one of your primary packaging suppliers, is crucial. the shorter, the better. Upon supply chain reliability lays market trust on the reliability of your company. Brand image exposure is certainly the least risk you might want to take. Patient’ trust in your brand is certainly one of your most valuable assets.

Risk to run out of time in a second source qualification

Relying on a single source may cause sleepless nights. Although your single supplier might have several production sites. Are you sure that those multiple production sites are real backups for the products you need? Are you sure that they do not rely themselves on single source suppliers? The timely qualification of a real alternate source can avoid those headaches. This wise step requires a proper management of the resources with anticipation. 

Which recommendations can we formulate to reduce the OOS risk and ease your supply of crimp caps ?

We trust you know most or what should or could be done, nevertheless we also know that some companies tend to delay what isn’t considered as urgent although it may be important.

Anticipate whenever possible the qualification of a second or a third source of supply

Depending on the budgeted volumes of your fill & finish production lines, you might even consider the audit and qualification of a third source of supply.

Prioritise and dedicate resources when these are available to secure a plan B on all packaging components  

It needs human and financial resources to qualify a proper alternate supplier of Flip-Off /Push-Off overseals. Ideally, the task force shall include QA specialists, Packaging engineers, as well as colleagues from production, marketing and Supply Chain, in order to properly audit and evaluate the supplier’s products, services, their suitability in your specific filling environment, as well as evaluation of reliability of its supply chain.

Ask a second supplier of flip-off cap to ease the qualification process by matching as close as possible your primary supplier protocol

The keyword here is the alternate supplier’s ability of “reverse engineering capabilities”. This important capability is a mind-set. It shows that you as a customer are right in the centre of his preoccupation. It’s an approach proving flexibility, agility and customer orientation which is - more than ever - key for success.

Fully benefit from the second flip-off cap sourcing option

The Flip-Off are a lot of benefits

Beyond the immediate short-term wins, generated by the qualification of a second source, you may want to also consider the following benefits :

A challenger is always good to have

Current times are called VUCA - an acronym of volatile, uncertain, complex and ambiguous. Who wants to depend on those times on a single source? Above all if it’s a market leader on whom you’re not able to leverage. By installing and nurturing an SME-alternate supplier, you might be able to install real, effective and permanent pressure on your main supplier to get the best from it.

Supply at least 20% of the outsider’s flip-off cap solution

Agility, flexibility, expertise are empty words until they’re proven regularly inside your teams. To make sure your production team masters the filling process with all the qualified packaging elements, it should regularly get the opportunity to prove it. Maybe this might be a challenging approach towards your production team at the beginning. But overtime, by giving your team the opportunity to get used to different suppliers, you’ll all get the benefits from it.

Benefit from the second source insights

Routines have their advantages….but not only. there’s always some space for improvements. Challenging existing practices is part of “Kai zen” or process of permanent improvement. It gives you and your team the opportunity to expand your knowledge and expertise of pharmaceutical packaging best practices.
 It’s a mind-set, also known as the “open innovation” approach; leading to product- or process improvements or even innovations, by opening up to other teams, other working experience, other company culture and service levels.

As a conclusion, whatever is your motivation to bring a second or a third Push-Off/ Flip-off cap supplier in your scope, we believe you will never regret it.

If you are now convinced to include another aluminum crimp cap supplier you may wonder where to start ?  The pharmaceutical market is a fully global market and you could be tempted to source from exotic countries offering attractive solutions.

In the next article we will review the options you could consider looking specifically at the pros and cons.