Pharmaceutical Packaging composite membrane technical features – technical, complex film, medical packaging – pharmaceutical industries
Drugs is a special commodity, Pharmaceutical Packaging Composite film as a direct contact with the pharmaceutical packaging materials, in addition to the special requirements of management, at the technical level, there are many differences.
1. Pharmaceutical packaging composite film features in the product standards
2002, promulgated the "Regulations for the Implementation of the PRC Drugs Act" expressly provides that direct contact with drug packaging materials, containers prescribed by the State Food and Drug Administration develops and released from Medical Packaging Standard management and technical supervision from the State Board moved to the State Food and Drug Administration. Since July 2002 more than two years since then, the State Food and Drug Administration issued a total of 49 Medical Packaging product standards, 25 Medical Packaging standard test methods. Its Traditional Chinese medicine Composite film product packaging standards YBB00132002 "drug packaging composite film, bags General", YBB00172002 "polyester / aluminum / polyethylene composite pharmaceutical packaging film, bags", YBB00182002 "low-density polyethylene polyester composite film for packaging medicines the bag ", YBB00192002" BOPP LDPE Film pharmaceutical packaging. " Pharmaceutical packaging standards mainly by the Shanghai composite films Pharmaceutical packaging materials Testing, packaging materials, the National Drug Research Testing Center, Zhejiang Province, pharmaceutical packaging inspection station and other units engaged in drafting.
Pharmaceutical packaging standard composite film, its preparation of the format is completely different from the national standards and industry standards, but with China Pharmacopoeia The preparation of the format. Its content, compared with the normal composite films, an increase of microbial toxicity of the two limits and abnormal health projects, and other health, safety index, compared with the food packaging has greatly improved. The inner lining of the composite strength and sub-provisions should be more than 2.5N/15mm, significantly higher than in composite film, but for appearance, size and other non-safety index, the standard did not give specific provisions. Pharmaceutical packaging composite film standard also provides pharmaceutical packaging composite film material must be identified and its structure, the packaging of other drugs should be YBB00142002 "drug packaging materials and drug compatibility test guiding principles" for compatibility testing, pharmaceutical packaging to ensure safe and effective.
Course, pharmaceutical packaging, the drafting of the standard composite membrane is not a lot of validation experiments and did not solicit opinions from all sides so there are many problems found after the release, need to be further improved.
2. Pharmaceutical packaging performance requirements of composite membrane barrier characteristics
High barrier packaging materials for food with the composite membrane, the general is the high resistance oxide material (such as PA, EVOH, etc.), but for drug packaging, the vast majority of drugs sensitive to moisture and oxygen are not sensitive, and thus pharmaceutical packaging moisture barrier is usually dominated.
Drugs is a high added value, security, special goods with high reliability requirements. Except Herbal Pieces And packaging of low-grade granules, the drug packaging essential to pure aluminum foil composite film-based composite materials, and food packaging in general are mainly transparent or aluminum packaging. Barrier aluminum composite material because of its high barrier, which could be ignored no longer be ignored side penetration. Made of composite materials with aluminum foil bags in addition to considering the penetration through packaging materials, the bags should be considered the infiltration heat sealing, heat sealing should have sufficient width, the use of sealing materials must have a certain barrier properties. I have taken in water vapor transmission rate for the 0.25g/m2? 24h (cup method 38 90% RH) composite film made of aluminum foil bags, will be fully dried by anhydrous calcium chloride sealed bag measuring weight, duration year, 50 100% RH measured under conditions: when the edge width is 8mm, aluminum foil composite film of water vapor transmission rate for the 0.0014g/m2? 24h. When the edge width is 20mm, aluminum foil composite film of water vapor transmission rate of only 0.0008g/m2? 24h. This shows that the width of sealing barrier bag aluminum composite effect. The results further show that the aluminum foil thickness above 15 m, Aluminum foil bags are totally determined by the barrier edge width and edge quality.
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