Testing standards for pharmaceutical packaging？
The pharmaceutical packaging testing standards are a set of mandatory technical specifications used to ensure the safety, effectiveness, and stability of drugs, centered around five dimensions: physical properties, chemical safety, biocompatibility, barrier properties, and sealing integrity. The current standard system in China is centered around the 2025 edition of the Chinese Pharmacopoeia, which integrates the original YBB national drug packaging material standards and references international standards such as ISO, USP, and EP.
1、 Chinese Pharmaceutical Packaging Material Standard System (Pharmacopoeia 2025 Edition)
Adopting the “1+4+58” core architecture:
One general principle: 9621 Guiding Principles for General Requirements of Drug Packaging Materials (Top Level Standards)
Four guiding principles for materials:
9622 Medicinal Glass Materials and Containers
9623 Medicinal Rubber Seals (New)
9624 Medicinal Plastic Materials and Containers (New)
9625 Medicinal Metal Materials and Containers (New)
58 universal testing methods: comprehensive coverage of physical, chemical, and biological performance testing of various materials.
2、 Core testing items and standards for the four mainstream materials
- Medicinal glass (Boston bottle, molded bottle, controlled bottle)
Core standards: ChP General Rule 9622, YBB 0009~0018 series, ISO 8362, USP<661>Key testing items:
Physical properties
Size and appearance: vertical axis deviation (≤ 1.0mm), bottle mouth thread, no bubbles/stones on the bottle body.
Internal pressure resistance: infusion bottle ≥ 0.6MPa, pressure holding without rupture.
Thermal shock (thermal shock resistance): does not explode when the temperature difference is ≥ 42 ℃ (4019 method).
Internal stress: Good annealing, no obvious stress birefringence.
chemical properties
Internal surface water resistance: graded (HC 1/2/3), controlling the precipitation of acidic substances.
Acid/alkali resistance: Quality loss and no change in appearance after acid and alkali erosion.
Dissolved substances: easily oxidizable substances (≤ 0.5mL), heavy metals (≤ 1 μ g/mL), arsenic salts.
Performance significance: Ensure chemical inertness, prevent glass peeling and heavy metal contamination of the drug solution. - Medicinal rubber (rubber stopper, gasket)
Core standards: ChP General Rule 9623, YBB 0004~0006 series, ISO 8871 Key testing items:
Physical and mechanical properties
Hardness (Shore A): controls elasticity and affects puncture feel.
Tensile strength/elongation at break: Ensure sealing and tear resistance.
Puncture force: Simulate needle puncture with moderate force value (such as 3-7N).
Puncture debris: ≤ 5 particles fall off after puncture.
Chemical and Safety Performance
Dissolved substances: non-volatile substances, heavy metals, sulfides, ammonium salts.
Biocompatibility: cytotoxicity, intradermal irritation, sensitization test (ISO 10993).
Performance significance: To prevent the rubber stopper from reacting with drugs (such as adsorbed proteins) and contaminating the drug solution with debris. - Medicinal plastics (infusion bags, PE bottles, composite films)
Core standards: ChP General Rule 9624, YBB 0007/0010 series, EU 10/2011 Key testing items:
barrier performance
Water vapor transmission rate: prevent moisture absorption and deterioration (4010 method).
Oxygen permeation rate: prevent oxidation (4007 method, newly added in the 2025 Pharmacopoeia).
Physical properties
Peel strength: The adhesive force between composite film layers is ≥ 1.5N/15mm.
Heat sealing strength: the ability of the seal to resist rupture.
Sealing: No leakage (negative pressure method).
Chemical Safety
Solvent residue: toluene, xylene, etc. ≤ 10mg/m ².
Migration/leachate: plasticizer (DEHP), antioxidant, total organic carbon (TOC). - Medicinal metal/composite packaging (PTP aluminum foil, cold formed aluminum, aluminum-plastic cover)
Core standards: ChP General Rule 9625, YBB 0012~0015 series Key testing items:
Physical properties
Folding resistance: Aluminum foil can be repeatedly bent without breaking.
Protective layer adhesion: The coating does not peel off.
Barrier and safety
Heavy metals: lead, cadmium, mercury, arsenic limit.
Coating leachables: No toxic substances precipitate.
3、 Universal safety testing (mandatory for all materials)
Sealing and integrity
Methods: Staining method, vacuum attenuation method (USP<1207>), high-voltage discharge method.
Standard: Maintain pressure (such as 15kPa) without leakage or bubbles.
Microbial Limit
Control the total number of bacteria, mold, and yeast.
Aseptic packaging requires sterile testing and bacterial challenge testing (antimicrobial resistance).
Drug compatibility test (core)
According to YBB 00142002 “Guidelines for Compatibility”.
Inspection: Whether the packaging material adsorbs the main components of the drug, whether it releases harmful substances, and whether the drug pH/content/related substances are stable.
Accelerated aging test
Simulate long-term storage (such as 6 months at 40 ℃/75% RH) to verify packaging performance within the validity period.
4、 Domestic vs International Standard Comparison
table
Project Chinese Standards (ChP/YBB) United States (USP) European Union (EP/ISO)
Glass 9622, YBB 0009<661>Glass EP 3.2.1, ISO 8362
Rubber stopper 9623, YBB 0004<381>Elastomers EP 3.2.9, ISO 8871
Plastic 9624, YBB 0010<661.1>Plastics EU 10/2011
Compatibility YBB 0014 USP<1664>ICH Q3, ISO 10993
summary
The core logic of pharmaceutical packaging testing standards is “protecting drugs, not contaminating drugs, and ensuring safety and reliability”. From the Boston glass bottles you previously focused on, the testing focus is on the light avoidance, water resistance, thermal shock strength, and sealing performance of amber glass with rubber stoppers. All indicators must strictly comply with the general requirements of the Chinese Pharmacopoeia before they can be used for drug packaging.