Rubber caps, an essential component to ensure the integrity of parenteral drugs

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.

Types of rubber stoppers for pharmaceutical use

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:

• Bromobutyl rubber: composed of a butyl elastomer base and a halogen bromine element, it is characterised by lower hygroscopicity, i.e. it has a lower tendency to absorb moisture. This is why it is recommended for pharmaceutical products that need to be freeze-dried.
• Chlorobutyl rubber: composed of a butyl elastomer base and a chloro-halogen element; it has a higher heat resistance.

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:

• Sulphur-based: widely used in the past and still in demand today for old pharmaceutical formulations still on the market.
• Non-sulphur-based: provides a lower level of extractables and is more suitable for complex pharmaceutical formulations.

The production of rubber stoppers for pharmaceutical use

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:

• Mixing: all the necessary ingredients, raw materials and additives, are mixed until a homogeneous mixture is obtained.
• Printing and vulcanisation: the rubber is then printed on rubber sheets that undergo a process of "vulcanization," which changes their molecular structure to increase their elasticity, strength, and viscosity.
• Trimming: the sheets are finally die-cut in order to obtain the rubber closures.
• Washing: The rubber is then washed and, in some cases, silicified. This usually takes place within a 'controlled contamination' environment, known as a clean room, where there is active air filtration and constant control of key environmental parameters. Accurate inspections are also carried out on 100% of the parts in the clean room, using high-resolution vision systems.
• Packaging: products are packed in individual bags ready for sterilisation, or are sterilised and shipped directly to the customer.

Scientific testing and quality of rubber stoppers for pharmaceutical use

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:

• physical-chemical tests
• functionality tests
• analysis of extractables

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.

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.

Specifications:

Disposable Heparin Caps 
Medical grade PVC material 
Luer lock connect port 
Yellow or transparent, Sterile EO

Disposable Combi Stopper made of medical grade ABS or PC, it is used for Sterile closing of all kinds of open IV-accesses in IV-Sets orSterile closing of pre-filled syringes.

1) Used for disposable syringe

Want more information on Heparin Cap Rubber Stopper manufacturer? Feel free to contact us.

2) With slick and intact appearance

3) Highly sealing and sliding performance

4) Material: ABS or PC

5) Color: Available in red and blue

6) Male/female luer lock fitting

7) Size: S, M, L

8) Rubber pistons for syringe size: 0.5ml. 1ml, 2ml, 5ml, 10ml, 20ml, 30ml, ect

Company Profile

SHANGHAI SUN-SHORE MEDICAL INSTRUMENTS have own factory and have CE and ISO certificate,which mainly handles in: Surgical Dressings, Medical Disposables, Laboratory Disposables, Medical Equipment,Safety & industrial protection products, Safety Protective. Our products have been sold to many countries and regions in the world such as Europe, America, Southeast Asia, Oceania, Middle East, Africa etc. Meanwhile we kept close relationships with many professional manufacturer and units in over 30 provinces to ensure a steady supply of goods. In order to meet request of increasing international request, control quality of product and guarantee steady supply.We are a professional & comprehensive enterprise with the status of legal entity in importing and exporting the Healthy and Pharmaceutical Medicine, Surgical & Medical Disposables and Equipments and all the related medical items including high-tech equipment researching and development as well.SHANGHAI SUN-SHORE MEDICAL INSTRUMENTS CO., LTD stick to the enterprise essence of "Serve the Clients, Heart and Soul,Survive on the base of the Quality, Developing on the base of the Technique, to make profit on the base of Management, and serve the market on the base of Reputation" , we operate our company in strictly accordance with the management system of ISO standard, emphasize the brand building, insists on enterprise spirit of " CREADIT FIRST, SUPERIOR QUALITY, MUTUTAL BENEFITS AND JOINT DEVELOPMENT ", absorb and import the advanced production technology and management concept from international well-know enterprises constantly to make sure the quality of our products achieve the international standard and obtain the trust and reputation of the customers around the world through providing high quality products and superior service.

FAQ

1. who are we?
We are based in Shanghai, China, start from ,sell to Africa(20.00%),Eastern Europe(10.00%),South America(10.00%),Mid East(10.00%),North America(10.00%),Western Europe(10.00%),Northern Europe(10.00%),Southern Europe(10.00%),South Asia(10.00%). There are total about 11-50 people in our office.

2. how can we guarantee quality?
Always a pre-production sample before mass production;
Always final Inspection before shipment;

3.what can you buy from us?
SURGICAL DRESSINGS,MEDICAL DISPOSABLES,LABORATORY DISPOSABLES,MEDICAL EQUIPMENT,OTHERS

4. why should you buy from us not from other suppliers?
SHANGHAI SUN-SHORE MEDICAL INSTRUMENTS have own factory and have CE and ISO certificate,which mainly handles in: Surgical Dressings, Medical Disposables, Laboratory Disposables, Medical Equipment,Safety & industrial protection products, Safety Protective.

5. what services can we provide?
Accepted Delivery Terms: FOB,CFR,CIF;
Accepted Payment Currency:USD,EUR,HKD,CNY;
Accepted Payment Type: T/T,L/C,D/P D/A,Western Union,Cash;
Language Spoken:English,Chinese

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