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2022

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07

Using pharmaceutical packaging inspections to proactively tackle the "big test" facing the pharmaceutical packaging industry.


On June 2, 2022, the National Medical Products Administration (NMPA) released the draft "Good Manufacturing Practice for Pharmaceutical Packaging Materials" on its official website, which will require pharmaceutical packaging material companies to implement stricter quality management measures. Pharmaceutical Packaging Inspection Highly prioritize, The country also provides guidance and oversight for pharmaceutical packaging material production activities and quality control practices. Let’s take a closer look below. Pharmaceutical Packaging Inspection Relevant matters.

 

Commonly used pharmaceutical packaging materials

It primarily includes three types of materials: glass, plastic, and rubber seals. From the perspective of environmental protection and energy-saving trends, packaging materials are evolving toward alternatives such as using paper instead of wood, replacing paper with plastic, or developing various composite materials made from combinations of paper, plastic, aluminum foil, and more.

Composite materials are a newly emerging type of packaging material, created by layering and combining plastics, paper, aluminum foil, and other components. These innovative materials are used to Pharmaceutical Packaging Inspection Relevant experimental data show that, Composite materials offer advantages such as excellent mechanical strength, resistance to biocorrosion, superior vacuum retention, and impressive compressive performance.

 

The form of pharmaceutical packaging

Currently in the pharmaceutical industry, common packaging formats include blister packs, ampoule packaging for water-based injections, flexible bottle packaging, strip packaging, and unit-dose packaging. Manufacturers typically select the appropriate packaging type based on the specific characteristics of the medication and Pharmaceutical Packaging Inspection Come and choose the specific packaging format.

Due to the varying types, compositions, and formulations of pharmaceutical packaging materials, their physical and chemical properties differ significantly. Consequently, the way these materials interact with different drugs after packaging also varies. Therefore, for each type of packaging material, decisions are made based on Pharmaceutical Packaging Inspection China The evaluation criteria, methods used, and results for drug compatibility tests also vary accordingly.

 

Performance Testing of Pharmaceutical Packaging Materials

According to relevant standards and specifications, Pharmaceutical Packaging Inspection The main control indicators include sealing performance, barrier properties, slip resistance, mechanical strength, solvent residues, thickness, cap torque, headspace gas analysis, and print quality, among others. Pharmaceutical Packaging Inspection 。

In addition to possessing certain mechanical properties, barrier performance, and excellent safety features, packaging materials must also have suitable processing capabilities and strong economic viability. As for Pharmaceutical Packaging Inspection From the perspective of national regulation, there is also a strong emphasis on performance-testing standards. Meanwhile, different pharmaceutical packaging materials… Pharmaceutical Packaging Inspection Projects and Pharmaceutical Packaging Inspection The testing equipment also varies.

Question: Where is the best place to get pharmaceutical packaging materials tested?

Typical pharmaceutical packaging material manufacturers target Pharmaceutical Packaging Inspection , will choose the local drug regulatory authority or a qualified third-party testing organization Pharmaceutical Packaging Inspection The institutions are all relatively authoritative; as for which one to choose… Pharmaceutical Packaging Inspection It really depends on what you need to do. Pharmaceutical Packaging Inspection Samples and testing items.

The center relies on sophisticated testing equipment, a professional packaging material compatibility team, and a dedicated drug analysis team. Pharmaceutical Packaging Inspection Highly experienced. Able to assist clients with all aspects of pharmaceutical packaging materials. Pharmaceutical Packaging Inspection , to ensure that pharmaceutical packaging effectively protects the quality of the medication.

 

The center's detection capabilities

Mechanical Properties: Tensile strength, elongation at break, peel strength, heat-seal strength (film/bag), and burst strength, among others

Barrier performance: Water vapor transmission rate, nitrogen transmission rate, and more

Performance usage: Differences in protective layer adhesion, adhesive coating weight, moisture content, environmental hygroscopicity, drop performance, and more

Material Identification: Infrared spectroscopy, density, and more

Safety Performance: Fluorescence of paper bags, residue after ignition, leachate testing, residual solvent levels, metal ions, and more

Microbial Limit: Bacterial count, mold count, yeast count, Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, and more

 

The center's testing scope for pharmaceutical packaging materials

Plastic pharmaceutical packaging materials: Bottle types, film bag types, composite rigid sheet types, and sealing gasket types

Rubber-based pharmaceutical packaging materials: Injection solution rubber stoppers and pharmaceutical-grade synthetic polyisoprene gaskets

Metal-based pharmaceutical packaging materials: Medicinal aluminum foil, aluminum caps for pharmaceutical packaging

Other categories: Solid medicinal paper bags filled with silica gel desiccant

Drug and Packaging Compatibility Studies

Turnover Equipment Testing

The pallets have full testing capabilities according to national, U.S., ISO, and other standards.

Pallet containers, compliant with industry standards and equipped with full testing capabilities.

 

Medicine Packaging Material Testing Standards Authorized by the Center

 

Relevant qualifications for central pharmaceutical packaging testing

 

The center thoroughly understands and researches multiple national standards for packaging materials and containers that come into direct contact with pharmaceuticals, enabling it to assist pharmaceutical manufacturers in their efforts. Pharmaceutical Packaging Inspection , Improve the pharmaceutical quality control system to efficiently address and resolve challenges for businesses.

 

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