Contract Manufacturing Services
In general, generic drug manufacturers have their own requirements on drug containers, such as the specific size and product standards. Huaren has the ability to design and produce rubber stoppers, even stoppers for sensitive molecules, as per customer’s request in a short time, which is conducive to launching new drug products in every market for generic drug manufacturers.
Huaren has its own analytical labs and also has cooperated with CFDA certified analytical institution. Our experienced group of analytical chemists is dedicated to the analytical development support of our products in all stages of development and production. And the analytical reports carried out by the CFDA certified analytical institution can be directly used for a part of registration information of a drug application in China.
PRODUCTION CONTROL SYSTEM
Huaren has established its own factory which is provided with an Class A+B clean workshop and two Class C clean workshops according to GMP standards and where scrupulous process control is implemented by our trained employees as per approved SOPs to safeguard the quality of our finished products.
Quality Management System
So far, the security of rubber stoppers has always been concerned.
The imported washing machine is used for cleaning, which overcomes the excessively intense leading to the destruction of the molecular structure of the rubber stopper and reduces the exfoliation of the particles. After Cleaning, Silicidation, and Drying, the rubber stoppers are cooled and packaged under the circumstance of the 100-Class clean area. And our rubber stopper has excellent compatibility with drugs, great heat resistance, acid &alkali resistance
In addition, our company has effectively solved the following problems of rubber stopper through research, development and a large number of tests.
(1) Dissolution problem
Although the chemical stability of the butyl rubber stopper is great and the materials used in the formulation are also fine, they are actually slowly oozing out to destroy the packaged drugs resulting in toxic side effects due to the concentration gradient.
Unstable substances in drug packaging materials transfer to drugs.
For example, the interaction between the medicine and the rubber stopper often makes the clarification of the drug unstable. The main reason is that the butyl rubber stoppers touch the drug directly after the capping, or the rubber stopper eructation interact with the drug during the sterilization process with high temperature & pressure (120 °C, 40 min). The main components of the eructation are raw rubber, oligomers, filler and rubber additives, etc. The content of the additives is not high, which could modify the rubber. But there is also free migration and the monomers in the polymer also migrate. The total amount of migration substances for rubber stopper during touching drug (shelf life) is one of the safety indicators affecting the drug.
Experiments have shown that when the rubber stoppers touch injection solution, the rubber stopper may absorb the active ingredient, the antibacterial preservative or other substances in the injection. And several components of the rubber stopper may also be leached into the solution. These extracts may interfere with the chemical analysis of the active ingredient causing the injection to produce toxicity or heat and interact with the drug's preservative to affect the chemical and physical stability of the formulation resulting in particle turbidity
Therefore, our company has continuously studied and discussed the compatibility between rubber stoppers and drugs for this problem according to the needs of different customers.
(2) Puncture Exfoliation
Although the butyl rubber stopper is superior to the natural rubber stopper in many aspects, the puncture exfoliation performance of the butyl rubber stopper is inferior to the natural rubber stopper. The stopper is pierced by the needle when the medicine is out causing partial rupture or even exfoliation, which poses a threat to drug contamination and medication safety.
The problem is improved by adjusting the rubber stopper.which has met warm receipt with many customers.
We strictly manufacture rubber stopper according to requirements with excellent raw materials and mature technology to ensure the quality of the products.