Product Description
Pharmaceutical Butyl Rubber Stopper offered by us, stopper is of the highest quality and is manufactured in compliance with the necessary criteria under secure and approved process conditions. This stopper is widely used in pharmaceutical industry for various purposes. This stopper is very easy to use and simple to handle. Pharmaceutical Butyl Rubber Stopper is employed not just to avoid spills, but also to capture toxic odors and to allow the vessel to be shaken. This stopper is very cost effective and can be easily purchased by our customers, at reasonable rates, in bulk quantities.
Product Specification
Material | rubber |
Type | Rubber Stopper |
Diameter | 13 to 33mm |
Color | Grey, Red |
Brand | Shyamwell Pack |
Shape | Round |
Superior Sterilization and Contamination ControlOur Butyl Rubber Stoppers are fully autoclavable, allowing effective steam sterilization, which results in safe integration with injectable medicines. Production is maintained in state-of-the-art ISO 7 or ISO 8 cleanrooms, ensuring precise control over microbial contamination and meeting rigorous pharmaceutical safety standards.
Comprehensive Regulatory ComplianceThese stoppers are manufactured in adherence with USP <381>, European Pharmacopoeia, and ISO 8362 requirements. Approved drug master files (DMF) are available, further supporting global regulatory submissions and facilitating seamless pharmaceutical operations.
Customizable Design and Material ExcellenceWith high chemical and moisture resistance, low water absorption, and strong tensile properties, our stoppers are available in various colors and sizes such as 13mm, 20mm, and 28mm, or customized to specific vial requirements. Synthetic butyl rubber guarantees no natural rubber content, minimizing allergenic risk.
FAQs of Pharmaceutical Butyl Rubber Stopper:
Q: How do Pharmaceutical Butyl Rubber Stoppers ensure compatibility with steam sterilization methods?
A: These stoppers are produced from synthetic butyl rubberspecifically chlorobutyl or bromobutylmaking them highly resistant to steam sterilization, including autoclaving procedures. Their composition and design preserve both integrity and sealing capability under high-temperature conditions.
Q: What steps are taken to control microbial contamination during the manufacturing process?
A: All stoppers are produced in ISO 7 or ISO 8 cleanroom environments where strict protocols are maintained to minimize microbial presence, ensuring each unit meets industry standards for endotoxin levels and remains pyrogen-free.
Q: When are these stoppers typically used in pharmaceutical applications?
A: Pharmaceutical Butyl Rubber Stoppers are used during vial sealing for injectable medicines, lyophilization processes, laboratory packaging, and other medical applications requiring stringent barrier protection and regulatory compliance.
Q: Where can I customize the size, color, or other specifications of these stoppers?
A: Customization is available directly through the manufacturer or supplier in India. Dimensions such as width, diameter, thickness, and color (grey, red, black, or custom) can be tailored to meet specific vial requirements and branding preferences.
Q: What benefits do these stoppers offer regarding extractables and leachables?
A: They meet USP <381> and European Pharmacopoeia requirements for extractables and leachables, ensuring minimal chemical migration into pharmaceutical products and maintaining drug safety and efficacy.
Q: How does the stoppers chemical resistance support pharmaceutical packaging?
A: High chemical and moisture resistance ensures stability upon contact with various liquid formulations, protecting both the medicine and packaging material from degradation or contamination and enhancing shelf life.