Pharmaceutical Intermediates BIB

-- Steady & Reliable Manufacturer --

High-purity, low-extractable BIB liners used for the sterile or ultra-clean packaging of non-active liquid pharmaceutical ingredients, media, or high-value chemical precursors.

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Introduction

Pharmaceutical Intermediates BIB packaging demands the highest levels of purity, often referred to as "ultra-clean" or "low-extractable" liners. Suzhou Jingle Packaging manufactures these bags using medical-grade or USP Class VI compliant resins, avoiding additives that could leach into the high-purity product. These bags are manufactured in controlled environments (e.g., ISO Class 8 cleanrooms) and are primarily used for bulk transport of non-active ingredients, cell culture media, or buffer solutions in the biotech and pharma sectors.

Strict batch control and certification of material purity are provided.

Specification

Purity Standard	USP Class VI or equivalent (Low Extractables)
Manufacturing Env.	ISO Class 8 or better Cleanroom (Controlled Environment)
Material	Additive-free PE or specialized medical-grade co-polymers
Fitment Type	Sanitary quick-connect or aseptic fittings (Often custom)
Traceability	Full material batch traceability to the raw resin supplier

Logistics & Global Compatibility

Audit Support: Provides comprehensive technical file documentation and material safety data for global pharmaceutical regulatory bodies (FDA}, EMA).
Global Supply Chain: Liners are compatible with standard 200L and 1000L pharmaceutical-grade drums/IBCs.
Sterile Option: Can be gamma irradiated post-manufacture to achieve a high Sterility Assurance Level (SAL).
Customization: Capability to develop custom fitments for proprietary bioreactor or filling systems.

FAQ

Q: Are these bags equivalent to pharmaceutical-grade bottles?
A: They offer comparable or superior purity and are more suitable for bulk transport, replacing multiple rigid containers with a single flexible liner.

Q: Is gamma irradiation sterilization standard?
A: No, it is an optional, high-cost service requested by the client to achieve a specific Sterility Assurance Level (SAL) for critical applications.

Q: Can these bags be used for active pharmaceutical ingredients (APIs)?
A: While technically possible, APIs often require even more specialized containment solutions. These bags are typically reserved for non-active liquid intermediates and excipients.

Advantages

Minimized Extractables: Specialized materials prevent trace chemicals from leaching into and contaminating the high-purity contents.
Contamination Control: Cleanroom manufacturing drastically reduces particulate and microbial load on the final product.
Regulatory Compliance: Provides the necessary purity documentation (CoC) required for GMP and pharmaceutical audits.
Safety and Efficiency: Flexible format is safer and more efficient than glass carboys or rigid plastic drums.

Application

Buffer and Media Solutions: Bulk packaging of sterile liquids used in biotech and cell culture labs.
High-Purity Water: Packaging WFI (Water for Injection) or HPW (High Purity Water) for non-active use.
Active Ingredient Precursors: High-value chemical intermediates that require ultra-clean transport.
Vaccine/Diagnostic Components: Non-active liquid components used in sensitive biological processes.

Suzhou Jingle Packaging Technology Co. Ltd.

The company is located at No. 758, Longqiao Road, Wujiang Economic Development Zone, Suzhou, about 5 minutes' drive from the G15W Wujiang South Expressway Exit. As a China Pharmaceutical Intermediates BIB Suppliers and Wholesale Pharmaceutical Intermediates BIB Company. ,The company is committed to providing high-quality products and all-round solutions to domestic and foreign customers, and actively exploring new markets with customers.
The company has an advanced bag-in-box production line designed independently, which can produce products of various specifications according to customer requirements to meet customer supply needs.
It mainly develops and produces liquid flexible packaging products suitable for storing food, beverages, and non-food fields, as well as related supporting filling equipment, sells the products produced by the company, and provides corresponding after-sales services.

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