When we talk about primary packaging for parenteral drugs, we mean an integrated packaging system usually consisting of: a bottle containing the medicine in liquid or powder form, a rubber stopper adhering to the neck of the bottle and a simple or ‘tear-off’ aluminium closure that wraps and secures it in turn.
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Rubber stoppers for pharmaceutical use, correctly called 'rubber stoppers', are clearly different from common rubber products for industrial and domestic use. The are used not just to seal the container, but also to perfectly isolate the medicine, ensuring sterility and preventing any form of contamination. Optimal performance requires top-quality formulations that ensure maximum rubber-drug compatibility.
Rubber stoppers for drugs are available in different sizes, types, shapes and configurations. With some slight variations, they are generally cylindrical and tapered in shape. Rubber stoppers are made to perfectly match the mouth of the most commonly used bottles and vials, with a diameter ranging from 13 to 32 mm.
As far as formulation of the rubber used is concerned, there are two different compounds that are widely used for pharmaceutical applications. Both ensure low gas permeability, good elasticity and strength during the curing process, thus avoiding the creation of elements that could be extracted from the drug formulation and alter it. The two compounds available are:
Each can be suitably treated to improve its elasticity, which is essential to ensure the rubber stopper's performance over time. This treatment is called vulcanisation and can be performed using two different methods:
Rubber stoppers are produced in a highly controlled environment, according to a strict quality management system, starting with the selection of ingredients, through to the formulation of compounds and the constant monitoring of international pharmacopoeia requirements. They are made following a very precise process comprising the following steps:
As with all primary packaging systems for pharmaceutical use, manufacturers of rubber stoppers must adhere to strict regulations, dictated by international bodies such as the FDA and Pharmacopeia. Regulatory obligations include numerous and repeated checks that must be carried out on products, such as:
In particular, the last test ensures full compatibility between the rubber stopper and the drug formulation.
In addition to these routine tests, 100 % of the rubber stoppers are inspected by advanced vision systems during the production cycle, which scan the entire product surface. This is used to check for visual defects and to check accuracy of size.
As a further guarantee of the absolute quality and safety of the product, part of the production phase - usually the one between washing and packaging - is carried out in environments designed to prevent biocontamination, where particle levels, temperature and air humidity levels are kept under control. Indeed, anyone entering the clean rooms must follow precise hygiene and dressing protocols to ensure that the monitored parameters are properly maintained. In addition, to ensure total asepticity, the washing machines automatically transfer the load to a more controlled environment, where the production cycle is completed.
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Once packed in sealed bags, the rubber stoppers can be delivered directly to the customer, who will then sterilise them and use them in their own capping systems. In this case we speak of RTS products, i.e. 'ready to sterilise', whereas rubber stoppers that are supplied already sterilised by the manufacturer are called RTU -'ready to use '.
Sterilisation is usually performed in one of two ways: through steam, or through gamma radiation. The second method is preferred in the pharmaceutical field due to the very high penetration power that radiation achieves, thus allowing greater flexibility with respect to the shape, size or complexity of the objects to be sterilised.
Closures on a container-closure system are a critical part of the packaging for a sterile product. These closures maintain the sterility of the pharmaceuticals and prevent any contamination.
What Are Container-Closure Systems?
Parenteral products are formulated and packaged to both be sterile and maintain their sterility during terminal sterilization processes. A crucial part of package design lies in their container-closure mechanism, which functions to keep the contents sterile and prevent any contamination after a needle is inserted. An example of this is enabling resealing of the vial once the needle is withdrawn. Manufacturers of these products must have confidence in their quality control, as well as in their validation processes.
Closures, also known as stoppers or bungs, are an important piece of the final packaging of a pharmaceutical. The most common type of stopper is known as an elastomeric closure. Elastomers are any materials that can maintain the same shape when a deforming force is removed (known as their viscoelasticity). Typically, the elastomer in these types of pharmaceutical closures is a synthetic rubber - a material strongly resistant to permeation by oxygen or water vapor.
Compliance with FDA regulations is critical for these types of stoppers. A variety of key points arise when determining the viability of the elastomer. Validation includes ensuring the product cannot be absorbed by rubber, that the rubber cannot leach with the product, and that the seal is effective both alone and when stored along with the product. The ideal container-closure will have low permeability to air and moisture and a high resistance to aging
The container-closure system is an essential part of the final presentation of a pharmaceutical product. It defines the closure, protection, and functionality of a container while ensuring the safety and quality of the drug product over the product shelf life.
MediZap has created a Ready-to-Use vial and closure solution that offers the greatest protection against leachables and extractables.
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