The promulgation of the 2025 edition of the Chinese Pharmacopoeia marks a new stage in China's drug quality control system. Among them, four new general rules have been added4018 Glass Ampoule Determination of Breaking ForceAt the level of the highest national drug standards, the introduction of ampoules as a key injection packagingFracture force performanceThe testing methods have been unified and standardized. This is not only an upgrade in regulatory compliance, but also an important opportunity for pharmaceutical companies to improve product quality, ensure clinical drug safety, and strengthen production quality control.

New Pharmacopoeia Standard: The Core Meaning and Significance of General Rule 4018

This newly added4018 Glass Ampoule Determination of Breaking ForceThe purpose of its formulation is clear: to provide a scientific and unified basis for determining the key indicators of the safety of glass ampoules. The breaking force of ampoules is directly related to the convenience and safety of opening by medical staff. Improper force values may lead to difficulties in opening and risks such as glass shards contaminating the medication.

The drafting of this method extensively referred to the National Standard for Pharmaceutical Packaging Materials (YBB), international standards (ISO 9187), and national standards（GB/T 2637）Ultimately, the collaborative unification of mainstream standards at home and abroad was achieved. This means that following this method for quality control not only meets the requirementsPharmacopoeia of the People's Republic of ChinaThe legal requirements have also laid a solid foundation for products to comply with multiple domestic and international standard systems.

Technical Analysis in Depth: Key Requirements and Implementation Points of the New Measurement Method

To execute accuratelyChinese Pharmacopoeia 2025 Edition, Part Four, General Principles 4018It is necessary to thoroughly understand its detailed regulations on instruments and methods.

1. Strict requirements for instruments and equipment
The general rules clearly stipulate that material testing machines or those that meet functional requirements can be usedAmpoule breaking force testerThe instrument'sThe indication error must be within ± 1% of the actual valueThis places high demands on the accuracy of its sensors and the stability of the entire machine. At the same time, the measurement range needs to cover 0-200N, with an accuracy of 0.1N, to ensure accurate and reliable measurement data for all specifications of ampoules from 1ml to 30ml.

2. Standardized experimental parameters

• Test speedUniformly set at 10 mm/min (unloaded) to ensure consistency of testing conditions and comparability of results.

• Bracket distanceAccording to different ampoule specifications, the distance between metal supports is strictly regulated (for example, 1-5ml is 36mm, 10-30ml is 60mm), which is the key to simulating actual hand bending angles and obtaining real force values.

• Key operation notesThe method emphasizes that when testing scored ampoules,The force applying component must be accurately positioned in the middle of the notch (notch downwards)Any deviation can lead to a significant increase in the measured breaking force value, which may result in misjudgment.

BST-01 Ampoule Breaking Force TesterA professional tool designed for pharmacopoeia compliance

face, confrontChinese Pharmacopoeia 2025 EditionChoosing an instrument specifically designed for compliance is crucial in meeting the new requirements.BST-01 Ampoule Breaking Force TesterFrom the beginning of the design, we comprehensively benchmarked against General Rule 4018 to ensure that every test is accurate, efficient, and traceable.

Core performance guarantee:

• High precision measurement and control systemBuilt in high-resolution force sensor, with an indication error of less than ± 1% over the full range, and a resolution of up to 0.01N, far exceeding the precision requirement of 0.1N in pharmacopoeia, ensuring accurate data.

• Fully automated compliance testingPre set standard testing program, automatically matching ampoules of different specificationsBracket distanceAnd strictly control itTesting speed of 10mm/minEliminate manual operation deviations.

• Intelligent breakpoint positioning assistanceFor point scored ampoules, the instrument is equipped with auxiliary positioning devices or clear guidance to ensure that the force point is always aligned with the center of the score, strictly following the standard annotation requirements.

The value of data beyond testing:

• One click generation of compliance reportThe instrument can automatically record, calculate, and generate detailed test reports containing force value curves and statistical data (such as mean and standard deviation), and its data format can be directly used for quality archives to meet audit requirements.

• Process monitoring and warningThrough statistical analysis of long-term and large-scale testing data, enterprises can draw fracture force control charts to monitor the stability of key production processes such as glass materials and wire drawing sealing in real time, achieving a transition from "post inspection" to“Process prevention”Upgrade the quality control.

Building a quality control system for the future

The implementation of the new pharmacopoeia standards has prompted companies to re-examine their quality control strategies. Integrate the breaking force test from a single terminal detection into the entire chain quality system from raw material entry to finished product release.

• Systematic sampling and validationEnterprises can establish a more scientific sampling plan based on the general rules, combined with production batch and process validation data. Increase testing frequency and sample size at critical junctures such as process changes and replacement of glass tube suppliers.

• Methodology Transfer and ConfirmationFor enterprises that have established YBB or ISO standard internal control methods, it is necessary to conductPharmacopoeia 4018 MethodCompare and confirm to ensure the consistency and compliance of the inspection results.

• Scalability to meet complex requirementsProfessional instrument suppliers can not only provide standard instruments, but also target enterprisesHigh throughput detection, online quality control, or special ampoule typesWe provide customized automation solutions and transformation services to meet the needs of intelligent upgrading.

Frequently Asked Questions (Q&A)

Q1: Currently, we are conducting tests according to YBB standards. What preparations do we need to make for the new pharmacopoeia?
A1：The core testing methods (such as speed and bracket distance) are basically consistent with YBB standards, ensuring a smooth transition. The key steps you need to take are:Conduct methodological confirmationProve that your existing instruments and operating procedures meet all the requirements for instrument accuracy (± 1% error) and operational details in Pharmacopoeia General Rule 4018, and update the internal quality control documents.

Q2: How to verify the requirement of "indication error within ± 1%" in the Pharmacopoeia General Rules?
A2：This needs to be achieved through regular calibration. It is recommended to use standard weights or force measuring instruments that have been verified by national metrology institutions. Multiple points (usually no less than 5 points) should be selected within the full range of the instrument for calibration to verify whether the indication error is within ± 1%. This work should be conducted at least once a year and calibration certificates should be kept.

Q3: Do test reports need to include force value data for all individual samples?
A3：Yes, this is a manifestation of the scientific nature of pharmacopoeia methods. In addition to determining whether it is qualified or not, record the specific force value of each sample and calculate itArithmetic mean and standard deviationcrucial. These statistical data can intuitively reflect the concentration trend and dispersion degree of the breaking force of a batch of products, and are valuable indicators for evaluating the stability and consistency of production processes.

Q4: If the breaking force of the ampoule is qualified, but there are small notches on the cross section, is it considered qualified?
A4：According to the positioning of General Rule 4018, it specifies the "determination method", and the specific "result judgment" needs to comply with the requirements of the relevant general rules of "Glass Containers for Drug Packaging". Usually, the breaking force is qualified andThe cross-section is flat without sharp edges or cracks beyond the shouldersIt is a condition that needs to be met simultaneously. If the force value is qualified but there are quality defects in the cross-section, it may still be judged as not meeting the safety requirements of the packaging material.

Q5: Can the BST-01 instrument adapt to the irregular ampoules or special specifications on our production line?
A5：The value of a professional supplier of material testing instruments lies not only in providing standard equipment, but also in their ability to solve non-standard problems. For the needs of irregular ampoules, non-standard scratch positions, or automated online detection, we can provideCustomized fixture design, testing program modification, and even whole line integration solutionWhen choosing a supplier, it is important to examine their past customized project cases and mechanical design capabilities.

The content of this article is for reference and discussion only, aiming to interpret standards and provide information. Please strictly follow the official version of the Chinese Pharmacopoeia and relevant national regulations for quality control of drug packaging. If you have any questions or find errors, please feel free to communicate with us for correction.