江苏华兰药用新材料股份有限公司

 

Cleanliness, chemical stability, air tightness and biological properties inside butyl rubber stopper are good, but due to complex formula and concentration gradient of material used, it may be absorbed, extracted or penetrated after packed with some drugs with strong molecular activity to lead to compatibility problem between rubber stopper and drug, especially part cephalosporin preparations, curative infusion preparations and many Chinese medical injection preparations. So select the above two inertia film materials to cover on surface where rubber stopper contacts with drug in order to separate direct contact between drug and rubber stopper, which can obviously improve its compatibility with drug.

 

Today, butyl compound film rubber stopper is widely applied on sealing packages and its safety and stability are approved, received and used by more and more pharmaceutical enterprises.

1. Current status of butyl compound film rubber stopper

After butyl rubber stopper is covered with inertia films, due to its multiple advantages, for example: a film layer is formed above surface of rubber stopper and position for drug contact to effectively reduce absorption, extract and penetration between rubber and drug, improve long-term stability of the drug, improve mechanical lubricity of the rubber stopper, greatly reduce the growth of insoluble pseudo-particles in drug liquid caused by silicon oil and reduce stringing of preparations for transfusion.

In foreign countries, production technology of butyl rubber stopper has been development for a longer time, for example Japan started to produce butyl rubber stopper in 1957 and developed countries in EU and US began mass production of pharmaceutical rubber stoppers in 1970; however, at home, mass production was started till 1922. Besides, compound film technology of butyl rubber stopper was developed earlier at abroad so their technology was relatively more mature, for example, The West Company in US, Crystal Zenith in Japan, Helvoet in Belgium, etc., which have various types of compound film butyl rubber stopper and which have strong capability for mass production; while at home, compound film technology of butyl rubber stopper was developed later, it is only Jiangyin Lanling Bottle Stopper Co., Ltd which is approved by SFDA and is capable to mass produce compound film butyl rubber stopper with stable quality and unique technical patent and intellectual property rights of the above two films.

2. Requirements for film material used for Lanlin's compound film butyl rubber stopper

Ultra low air permeability;

Ultra strong vapour-resistant permeability;

High chemical resistance;

High aging resistance;

High internal cleanliness;

Good ozone resistance and weather resistance;

Stable radiation sterilization;

non-toxicity, odourless, pollution-free;

Better elasticity.

3. Two film materials used by Lanling:

(POLYESTER) with (PET) for short, PET film material for original large transfusion pad;

(TEFLON) ;

(Poly-P-xylylene) with (Parylene .N.C) for short;

Vacuum coated film is required; processing with special equipment (Lanling is registering and applying for approval).

4. Basic process of butyl compound film rubber stopper

Technology of compound film

PET & Teflon films are used in this technology. Hereinto, Teflon film is an inert material and its technical products are used in food and pharmaceutical industries, which are approved by FDA, US. For its material properties, it is expressed that high-bond energy carbon-fluorine bond exists in molecular structure of fluorine resin and shielding effect is formed by atom of fluorine outside carbon chain. So Teflon has excellent drug resistance; PET film has good physical & chemical properties, even near Teflon. But the only defect is such film has no extensibility so forming of compound film rubber stopper is harder and its process is more complex. Compared with processing conditions of Teflon and Parylene .N.C, compound PET film has its own advantages: lower price, easier process. This film has good flatness, high single-face activating disposal level so it appears wider application space in drug separation.

Process:
Vacuum molding, curing & forming
Neck forming
Neck die-cut
Neck & crown curing & bonding forming
Neck compound film forming rubber stopper
Diw-cut
Clean & pack 

Technology of Lanling's compound film rubber stopper has advantages such as: heat sealing process never use any organic solvent or binding material and after high temperature of 180-200℃ and high pressure of 380 ton, strong adhesive force to rubber stopper and film, so no chemical residue; surface treatment isn't carried out to film directly contacting drug, so extreme small surface tension can reduce absorption of drug; good compactness of film can guarantee excellent shielding effectiveness and drug stability; no film is formed at sealing position of rubber stopper or bottle neck through the secondary forming, so air tightness problem that everyone concerns is absolutely solved.

 

5. Development trend for application of butyl compound film rubber stopper

As compared with status of application of world butyl compound rubber stoppers in pharmaceutical packaging field on a basis of the above introduction, good social benefits and economic gains can be achieved, which has the advantages below:

Elasticity and flexibility of film is good and even.

Film has good biological stability and compatibility, for which strict biological tests are carried out including acute systemic toxicity and subcutaneous toxicity; and which are approved by FDA of US.

 

Film won't fallen off after combined with butyl rubber stopper so secondary pollution won't happen.

Film has good separation performance in order to effectively prevent drug liquid being absorbed by metal ions in butyl rubber stopper.

Good lubricity. Movement of butyl rubber stopper exists in packing process of drug liquid, so good lubricity can ensure high efficiency of butyl rubber stopper on conveyor track in order to guarantee production efficiency of pharmaceutical enterprises.

Unique appearance design of compound film rubber stopper effectively ensure no jumping-stopper on high-speed repacking conveyor line in order to greatly improve production efficiency, OK rate of non-pollution of drugs and economic benefits.

Film has good thermal stability and resistance to high-temperature sterilization as butyl rubber stopper has various sterilization processes in different drug liquid, such as high-pressure moist heat sterilization, dry heat sterilization, radiation sterilization, etc.

Unique lubricity on surface of compound film rubber stopper, no matter how long cleaning and potching is spent on, stopper is smoothly fed on any automatic production line without siliconization and stringing is obviously reduced with ordinary rubber stopper for packing.

Process is easy, safe and efficient, it is a reliable guarantee for ultra-strong competitiveness with foreign compound film rubber stoppers as well as drug safety, effectiveness and stability. This product is covered insurance of PICC.

Hualan Science & Technology Co., Ltd -- Lanling Bottle Stopper