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What are the applications of multi-layer vacuum inner bags in the pharmaceutical industry
source：www.czxdc.cn | Release time：2025-11-25
The multi-layer vacuum inner bag, with its core characteristics of high barrier properties (oxygen, water, light, and odor), excellent sealing performance, strong chemical stability, safety, and non toxicity, can extend product shelf life and prevent contamination through vacuum/nitrogen filling packaging. It fully meets the strict requirements of the pharmaceutical industry for packaging that is "sterile, stable, safe, and compliant". The following are the main application scenarios of it in the pharmaceutical industry, classified according to product types and industry compliance standards:
1、 API and intermediate packaging (core application scenarios)
1. Solid raw materials (powders, granules, crystals)
Application Scenario:
Chemical raw materials: core raw materials such as antibiotics, vitamins, antihypertensive drugs, etc. are packaged in multi-layer vacuum inner bags (usually "PET/AL/PE" or "PET/AL/PP" structure) to isolate oxygen and moisture, prevent oxidation, moisture absorption and deterioration of raw materials (such as cephalosporin raw materials that are prone to oxidation, multi-layer aluminum foil composite bags can achieve oxygen permeability ≤ 0.1cm 3/(m 2 · 24h · atm));
Biological raw materials: such as protein and peptide raw materials, need to be packaged in sterile multi-layer vacuum bags, filled with nitrogen (or argon) after vacuum, to avoid microbial contamination and oxidative degradation, while meeting GMP requirements for "sterile packaging";
Chinese herbal raw materials: such as Chinese herbal extracts, Chinese herbal powders (such as Huangqi extract, Sanqi powder), multi-layer vacuum inner bags can block moisture and odors, prevent Chinese herbal ingredients from moldy and volatile, and extend storage life.
Core requirements: high barrier properties, sterility, puncture resistance (suitable for friction and stacking during the transportation of active pharmaceutical ingredients), compliance with USP (United States Pharmacopeia), EP (European Pharmacopoeia) or Chinese Pharmacopoeia restrictions on the dissolution and migration of pharmaceutical packaging materials.
2. Liquid raw materials and intermediates
Application Scenario:
Pharmaceutical intermediates (such as key intermediate solutions and suspensions for synthetic drugs) are lined with multi-layer vacuum inner bags (inner layer made of solvent resistant PE or PP material) and hard barrels (such as HDPE barrels and iron barrels). After vacuum sealing, liquid leakage and volatilization are prevented, while external oxygen and moisture intrusion are blocked to ensure the chemical stability of the intermediates;
Aseptic drug solutions (such as injection solvents and diluents) are packaged in sterile multi-layer co extruded film vacuum inner bags to meet the storage and transportation needs after aseptic filling and avoid secondary contamination.
Core requirements: Solvent corrosion resistance, leak free sealing, sterile production environment (compliant with ISO 13485 Medical Device Quality Management System).
2、 Packaging of formulated products (terminal drug protection)
1. Solid preparations (tablets, capsules, granules)
Application Scenario:
Preparations with high stability requirements, such as long-acting antihypertensive drugs, antibiotic capsules, and probiotic particles, are packaged in an "outer paper box+inner multi-layer vacuum bag". After vacuum (or nitrogen filling) sealing, they are isolated from oxygen, moisture, and light to prevent discoloration, decreased disintegration, and loss of active ingredients (such as probiotic particles, which require strict oxygen blocking, otherwise the number of viable bacteria will rapidly decline);
Large packaging preparations (hospital use large-sized tablets, bulk granules purchased by pharmacy chains), multi-layer vacuum inner bags can replace the traditional aluminum-plastic blister packaging form, reduce packaging costs, and improve barrier properties, adapting to the long-term storage needs of hospital pharmacies and chain pharmacies.
Core requirements: Food and drug grade safety materials (inner layer made of PE/PP, odorless and non migratory), light blocking properties (some formulations need to avoid light, combined with aluminum foil composite layer), easy to tear design (convenient for pharmacies to separate).
2. External preparations (ointment, gel, lotion)
Application Scenario:
Packaging lining for topical ointments (such as antibiotic ointments): Multiple layers of vacuum inner bags are used as inner packaging for ointment hoses and aluminum tubes. After vacuum sealing, the ointment is protected from oxidation and moisture, and chemical reactions between packaging materials and ointment are avoided;
Medical cleaning agents (such as disinfectant cleaning agents, Chinese medicine external cleaning agents): Large sized cleaning agents (hospital use 500ml or more) use multi-layer vacuum inner bags combined with HDPE pots to prevent the cleaning agents from evaporating and contaminating after vacuum sealing. The inner bag material is acid and alkali resistant and does not react with the ingredients of the cleaning agents.
Core requirements: Chemical inertness (does not react with the ingredients of the formulation), sealing without leakage, and resistance to rubbing (suitable for compression during formulation transportation).
3、 Packaging of medical devices and consumables
1. Sterile medical devices (disposable)
Application Scenario:
Invasive medical devices, such as disposable syringes, infusion sets, and urinary catheters, are packaged in "multi-layer vacuum inner bags+ethylene oxide sterilization". The inner bag material is PET/PE or PET/PP co extruded film, which is vacuum sealed to ensure sterilization effect (ethylene oxide gas can penetrate, leaving no residue after sterilization), while blocking microbial contamination. The shelf life can reach 1-3 years;
Medical dressings: such as sterile gauze, cotton swabs, wound dressings, packaged in multi-layer vacuum inner bags to prevent moisture absorption and mold growth, and the sterile barrier performance meets the YY/T 0681 standard for medical device packaging materials.
Core requirements: Aseptic barrier performance, breathability and bacterial permeability (adapted to sterilization processes), easy to tear design (convenient for rapid clinical opening), biocompatibility.
2. High value medical device accessories
Application Scenario:
Surgical instrument accessories (such as surgical blade heads and stapler accessories): packaged in multi-layer vacuum inner bags to prevent rusting and oxidation of the accessories (some accessories are made of metal material and require oxygen and moisture resistance), while avoiding wear and tear during transportation;
Medical sensors and electrode pads: The multi-layer vacuum inner bag can block moisture and electromagnetic interference, protect the sensitivity of the sensor, and the inner bag material is soft and does not damage the surface of the accessories.
Core requirements: Anti oxidation, anti-wear, dust-proof sealing, and compliance with biosafety requirements for medical device packaging.
4、 Other special medical scenarios
1. Packaging of drugs for clinical trials
Application scenario: New drugs (raw materials, formulations) in the clinical trial stage are packaged in small batches using multi-layer vacuum inner bags. After vacuum and nitrogen sealing, the stability of the drugs during long-term transportation and storage is guaranteed. At the same time, the inner bags can be customized with printed trial numbers, expiration dates, and other information for easy traceability management.
Core requirements: customized size, high barrier properties, traceability, and compliance with GMP requirements for clinical trial drug packaging.
2. Packaging for pharmaceutical products stored at low temperatures
Application scenario: Pharmaceutical products that require low-temperature storage (-20 ℃~-80 ℃), such as biological vaccines, stem cell preparations, and cold chain raw materials, are packaged in low-temperature resistant multi-layer vacuum inner bags (with an inner layer of low-temperature resistant PE material that can withstand -80 ℃ without cracking). After vacuum sealing, they prevent water from entering the low-temperature environment and causing product freezing and deterioration, while also adapting to temperature fluctuations during cold chain transportation.
Core requirements: low temperature resistance, high barrier properties, leak free sealing, and no risk of material brittleness at low temperatures.
Core compliance and performance requirements for selecting multi-layer vacuum inner bags in the pharmaceutical industry
1. Material compliance: The inner layer must use food and drug grade materials (such as PE, PP, EVOH), comply with Chinese GMP, US FDA, EU CE and other certifications, and have no odor or migration;
2. Barrier performance: Select the structure according to product requirements, including oxygen barrier type (including aluminum foil AL or EVOH layer), water barrier type (including PET or PA layer), and light barrier type (including aluminum foil or light shielding film layer);
3. Sterility requirements: The inner bags that come into direct contact with drugs or sterile medical devices must be produced in a cleanroom with a cleanliness level of 100000 or above and meet the sterile inspection standards;
4. Chemical stability: does not react chemically with pharmaceutical products, is resistant to acid, alkali, and solvents (adapted to the composition characteristics of raw materials and formulations);
5. Packaging process adaptation: It can be adapted to vacuum packaging machines and nitrogen filling packaging machines, with a sealing strength of ≥ 15N/15mm (in accordance with GB/T 10004 plastic composite film and bag standards for packaging).
1、 API and intermediate packaging (core application scenarios)
1. Solid raw materials (powders, granules, crystals)
Application Scenario:
Chemical raw materials: core raw materials such as antibiotics, vitamins, antihypertensive drugs, etc. are packaged in multi-layer vacuum inner bags (usually "PET/AL/PE" or "PET/AL/PP" structure) to isolate oxygen and moisture, prevent oxidation, moisture absorption and deterioration of raw materials (such as cephalosporin raw materials that are prone to oxidation, multi-layer aluminum foil composite bags can achieve oxygen permeability ≤ 0.1cm 3/(m 2 · 24h · atm));
Biological raw materials: such as protein and peptide raw materials, need to be packaged in sterile multi-layer vacuum bags, filled with nitrogen (or argon) after vacuum, to avoid microbial contamination and oxidative degradation, while meeting GMP requirements for "sterile packaging";
Chinese herbal raw materials: such as Chinese herbal extracts, Chinese herbal powders (such as Huangqi extract, Sanqi powder), multi-layer vacuum inner bags can block moisture and odors, prevent Chinese herbal ingredients from moldy and volatile, and extend storage life.
Core requirements: high barrier properties, sterility, puncture resistance (suitable for friction and stacking during the transportation of active pharmaceutical ingredients), compliance with USP (United States Pharmacopeia), EP (European Pharmacopoeia) or Chinese Pharmacopoeia restrictions on the dissolution and migration of pharmaceutical packaging materials.
2. Liquid raw materials and intermediates
Application Scenario:
Pharmaceutical intermediates (such as key intermediate solutions and suspensions for synthetic drugs) are lined with multi-layer vacuum inner bags (inner layer made of solvent resistant PE or PP material) and hard barrels (such as HDPE barrels and iron barrels). After vacuum sealing, liquid leakage and volatilization are prevented, while external oxygen and moisture intrusion are blocked to ensure the chemical stability of the intermediates;
Aseptic drug solutions (such as injection solvents and diluents) are packaged in sterile multi-layer co extruded film vacuum inner bags to meet the storage and transportation needs after aseptic filling and avoid secondary contamination.
Core requirements: Solvent corrosion resistance, leak free sealing, sterile production environment (compliant with ISO 13485 Medical Device Quality Management System).
2、 Packaging of formulated products (terminal drug protection)
1. Solid preparations (tablets, capsules, granules)
Application Scenario:
Preparations with high stability requirements, such as long-acting antihypertensive drugs, antibiotic capsules, and probiotic particles, are packaged in an "outer paper box+inner multi-layer vacuum bag". After vacuum (or nitrogen filling) sealing, they are isolated from oxygen, moisture, and light to prevent discoloration, decreased disintegration, and loss of active ingredients (such as probiotic particles, which require strict oxygen blocking, otherwise the number of viable bacteria will rapidly decline);
Large packaging preparations (hospital use large-sized tablets, bulk granules purchased by pharmacy chains), multi-layer vacuum inner bags can replace the traditional aluminum-plastic blister packaging form, reduce packaging costs, and improve barrier properties, adapting to the long-term storage needs of hospital pharmacies and chain pharmacies.
Core requirements: Food and drug grade safety materials (inner layer made of PE/PP, odorless and non migratory), light blocking properties (some formulations need to avoid light, combined with aluminum foil composite layer), easy to tear design (convenient for pharmacies to separate).
2. External preparations (ointment, gel, lotion)
Application Scenario:
Packaging lining for topical ointments (such as antibiotic ointments): Multiple layers of vacuum inner bags are used as inner packaging for ointment hoses and aluminum tubes. After vacuum sealing, the ointment is protected from oxidation and moisture, and chemical reactions between packaging materials and ointment are avoided;
Medical cleaning agents (such as disinfectant cleaning agents, Chinese medicine external cleaning agents): Large sized cleaning agents (hospital use 500ml or more) use multi-layer vacuum inner bags combined with HDPE pots to prevent the cleaning agents from evaporating and contaminating after vacuum sealing. The inner bag material is acid and alkali resistant and does not react with the ingredients of the cleaning agents.
Core requirements: Chemical inertness (does not react with the ingredients of the formulation), sealing without leakage, and resistance to rubbing (suitable for compression during formulation transportation).
3、 Packaging of medical devices and consumables
1. Sterile medical devices (disposable)
Application Scenario:
Invasive medical devices, such as disposable syringes, infusion sets, and urinary catheters, are packaged in "multi-layer vacuum inner bags+ethylene oxide sterilization". The inner bag material is PET/PE or PET/PP co extruded film, which is vacuum sealed to ensure sterilization effect (ethylene oxide gas can penetrate, leaving no residue after sterilization), while blocking microbial contamination. The shelf life can reach 1-3 years;
Medical dressings: such as sterile gauze, cotton swabs, wound dressings, packaged in multi-layer vacuum inner bags to prevent moisture absorption and mold growth, and the sterile barrier performance meets the YY/T 0681 standard for medical device packaging materials.
Core requirements: Aseptic barrier performance, breathability and bacterial permeability (adapted to sterilization processes), easy to tear design (convenient for rapid clinical opening), biocompatibility.
2. High value medical device accessories
Application Scenario:
Surgical instrument accessories (such as surgical blade heads and stapler accessories): packaged in multi-layer vacuum inner bags to prevent rusting and oxidation of the accessories (some accessories are made of metal material and require oxygen and moisture resistance), while avoiding wear and tear during transportation;
Medical sensors and electrode pads: The multi-layer vacuum inner bag can block moisture and electromagnetic interference, protect the sensitivity of the sensor, and the inner bag material is soft and does not damage the surface of the accessories.
Core requirements: Anti oxidation, anti-wear, dust-proof sealing, and compliance with biosafety requirements for medical device packaging.
4、 Other special medical scenarios
1. Packaging of drugs for clinical trials
Application scenario: New drugs (raw materials, formulations) in the clinical trial stage are packaged in small batches using multi-layer vacuum inner bags. After vacuum and nitrogen sealing, the stability of the drugs during long-term transportation and storage is guaranteed. At the same time, the inner bags can be customized with printed trial numbers, expiration dates, and other information for easy traceability management.
Core requirements: customized size, high barrier properties, traceability, and compliance with GMP requirements for clinical trial drug packaging.
2. Packaging for pharmaceutical products stored at low temperatures
Application scenario: Pharmaceutical products that require low-temperature storage (-20 ℃~-80 ℃), such as biological vaccines, stem cell preparations, and cold chain raw materials, are packaged in low-temperature resistant multi-layer vacuum inner bags (with an inner layer of low-temperature resistant PE material that can withstand -80 ℃ without cracking). After vacuum sealing, they prevent water from entering the low-temperature environment and causing product freezing and deterioration, while also adapting to temperature fluctuations during cold chain transportation.
Core requirements: low temperature resistance, high barrier properties, leak free sealing, and no risk of material brittleness at low temperatures.
Core compliance and performance requirements for selecting multi-layer vacuum inner bags in the pharmaceutical industry
1. Material compliance: The inner layer must use food and drug grade materials (such as PE, PP, EVOH), comply with Chinese GMP, US FDA, EU CE and other certifications, and have no odor or migration;
2. Barrier performance: Select the structure according to product requirements, including oxygen barrier type (including aluminum foil AL or EVOH layer), water barrier type (including PET or PA layer), and light barrier type (including aluminum foil or light shielding film layer);
3. Sterility requirements: The inner bags that come into direct contact with drugs or sterile medical devices must be produced in a cleanroom with a cleanliness level of 100000 or above and meet the sterile inspection standards;
4. Chemical stability: does not react chemically with pharmaceutical products, is resistant to acid, alkali, and solvents (adapted to the composition characteristics of raw materials and formulations);
5. Packaging process adaptation: It can be adapted to vacuum packaging machines and nitrogen filling packaging machines, with a sealing strength of ≥ 15N/15mm (in accordance with GB/T 10004 plastic composite film and bag standards for packaging).
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