High-standard one-stop testing solutions for the pharmaceutical and packaging materials industries
Deeply integrating the world's leading testing technologies, strictly benchmarking against domestic and international pharmacopoeias and regulatory standards, we have launched a one-stop, high-standard solution for pharmaceutical packaging in terms of "integrity, barrier properties, safety, and compatibility."
Pharmaceutical packaging is more than just a container for products; it is an indispensable component of pharmaceuticals and the lifeline that ensures their safety, effectiveness, and stability. With increasingly stringent domestic and international pharmaceutical regulations (such as FDA 21 CFR, Chinese Pharmacopoeia, and ICH guidelines), coupled with the rapid development of novel drug delivery systems and high-value biologics, unprecedentedly high standards are being placed on the quality control and innovative R&D of pharmaceutical packaging materials.
Facing this daunting challenge, we have deeply integrated the world's leading testing technologies, rigorously benchmarked against domestic and international pharmacopoeias and regulatory standards, and launched a one-stop, high-standard solution for pharmaceutical packaging integrity, barrier properties, safety, and compatibility. This solution is designed to provide pharmaceutical companies, pharmaceutical packaging material manufacturers, and authoritative quality inspection and research institutions with a scientific basis throughout the entire R&D, quality control, and release process, safeguarding the entire drug lifecycle.
Core of the solution: Benchmarking against pharmacopoeia regulations and building four gold standard modules
Based on the extreme requirements of pharmaceutical packaging for sterile barrier, compatibility, mechanical protection and regulatory compliance, we have precisely selected the following core instruments to build four key testing modules:
Integrity & Barrier Performance Core Module (ensuring drug stability)
This module is the cornerstone for ensuring that drugs are not affected by environmental factors and deteriorate and become ineffective during their shelf life, and is a top priority in pharmaceutical packaging material research.
Solution Value：
Gas transmission rate testers, oxygen transmission rate testers, and water vapor transmission rate testers are used to accurately quantify the barrier properties of packaging materials to oxygen and water vapor. This is crucial for evaluating the packaging design of easily oxidizable drugs (such as vitamins and biologics) and hygroscopic drugs (such as tablets and capsules). The data directly supports the determination of drug shelf life.
Seal testers (negative pressure method) and leak and seal strength testers are used for non-destructive testing of the overall seal integrity of packaging containers to ensure the microbial barrier function of sterile products (such as injections and eye drops) in strict compliance with pharmacopoeia standards such as USP〈1207〉.
Safety & Compatibility Study Module (eliminating contamination and migration)
This module is directly related to drug safety and is the core research information that must be provided when applying for drug registration. It complies with GMP and GLP regulations.
Solution Value：
Gas chromatography (GC) is the ultimate tool for extractables and leachables (E&L) studies. It is used for qualitative and quantitative analysis of volatile organic compounds, additives, monomers, and other substances in packaging materials that may migrate into pharmaceuticals. It is the gold standard for assessing the compatibility of pharmaceutical packaging materials with pharmaceuticals, meeting the stringent review requirements of the FDA and NMPA.
High-precision electronic balance is the basis of all precision weighing, ensuring the accuracy of experimental data.
The solvent moisture tester is used to accurately measure the trace moisture content in pharmaceutical packaging materials and their production environment (such as clean rooms) to ensure the stability, safety and effectiveness of drugs.
Mechanical performance & ease of use test module (to ensure production and medication)
Simulate the challenges your packaging will face on the production line and the end-user experience to ensure reliable functionality and ease of use.
Solution Value：
The electronic tensile testing machine can test the peel strength of the composite film layer, the pull-out force of the rubber stopper, the tensile strength of the medicinal aluminum foil, etc., to ensure the firmness of the packaging structure.
The bottle cap torque tester is used to control the opening torque of child safety caps (CR caps). It can prevent children from opening the cap while ensuring that the elderly can open it normally. It is the key to humanized design.
The falling dart/falling ball impact tester evaluates the impact resistance of film bags to prevent damage caused by external impact during transportation.
The burst tester can prevent the package from accidentally breaking, which may cause the drug to be contaminated, damp or leak, thus ensuring the physical integrity of the drug within its shelf life.
The friction coefficient tester is used to test the smoothness of the inner and outer surfaces of various pharmaceutical films and foils. The pharmaceutical packaging material standards have clear limit values for the friction coefficient of most film materials. It is a must-test item for incoming and outgoing factory inspections.
Process Validation & Stability Study Module (Simulating Extreme Conditions)
Verifying the reliability of packaging systems under sterilization processes and long-term storage conditions is a core part of drug release and stability studies.
Solution Value：
The counter-pressure high-temperature cooking sterilizer is specially used to simulate the wet heat sterilization process (such as 121°C) of terminal sterilization packaging such as infusion bags, glass bottles, and plastic bottles to test whether their sealing integrity and physical properties are intact under such extreme conditions.
Constant temperature and humidity chambers are used to conduct long-term stability tests on drugs (e.g., 25°C ± 60% RH, 40°C ± 75% RH), accelerate the prediction of aging behavior of drug packaging materials during storage, and provide supporting data for determining the shelf life of drugs.
Heat sealers are used to develop and verify heat sealing process parameters for pharmaceutical bags and pouch-like packaging, ensuring the consistency and reliability of sealing on the production line.
Solution advantages and features
Regulatory Compliance
The solution design strictly adheres to global pharmacopoeias and core medical packaging standards such as USP, EP, ChP, ISO 11607-1/-2, helping companies easily pass audits and certifications from domestic and international regulatory agencies.
risk aversion
Through scientific E&L research and complete sealing verification, the risks of drug recalls, reduced efficacy and safety incidents caused by packaging problems are greatly reduced, protecting patient safety and corporate reputation.
R&D empowerment
Provide comprehensive performance evaluation and data support for the research and development of new drug delivery systems (such as prefilled syringes and biological product packaging), intelligent packaging, and green and environmentally friendly packaging materials, driving industry innovation.
Full-cycle quality control
Covering the entire life cycle from packaging material raw material warehousing, production process control, finished product inspection to drug stability assessment, we build a seamless quality monitoring system.
As the pharmaceutical industry moves toward high-quality development, pharmaceutical packaging materials have evolved from "supporting products" to "critical components." This one-stop, high-standard testing solution aims to provide rigorous, precise, and reliable testing tools and methodological support. Working with colleagues in the pharmaceutical industry, we aim to build a strong foundation to safeguard drug quality and patient safety, using the power of technology to ensure the safety of patients.
Tel：13556033107
E-mail：gzsnyq@vip.163.com 
