Selection and requirements of packaging materials for injectable drugs
In addition to the control of drug quality in accordance with the provisions of the product section of the Pharmacopoeia, countries also carry out material control of drug packaging materials. For example, Japan Pharmaceutical Administration (JP15), European Pharmacopoeia (EP6), United States Pharmacopoeia (USP31), British Pharmacopoeia (BP2008} all contain the requirements for pharmaceutical packaging materials and containers.
The packaging form of large-volume injections is divided into two categories according to whether air is needed during injection.
(1) No additional air is needed during injection. This packaging form squeezes liquid into the body through the deformation of the packaging container during injection. It can avoid contamination of the liquid in the injection environment. It comes in three types of packaging: bag, boat and soft bottle.
Bag - shaped material: mainly has multilayer co-extrusion film. PVC film.
Ship shape material: PP. At present, no declaration of registration.
Soft bottle material: PE material is generally used, but PE is limited by F0.
(2) Air needs to be added during injection.
This form of packaging produces static pressure difference between the height of the packaging container and the body when injected, and squeezes the liquid into the body. Air must be added during injection to prevent a vacuum, and this air is taken directly from the infusion room, so it cannot avoid contamination of the solution in the event of adverse injection environment (e.g. bacteria, particulates). It has two kinds of packaging materials: glass, plastic. Among them, the glass material has sodium
Calcium glass, borosilicate glass. Plastic materials are PP and PE.
Small volume injections can be divided into three types according to the process, namely solution, sterile powder, frozen in dry sterile powder injection. Their packaging form is solution type small capacity injection using ampoule packaging; Sterile powder small volume injection is used. Borosilicate glass injection control bottle, low borosilicate glass injection control bottle, or sodium calcium glass molded injection bottle; Freeze-dried powder small capacity injection using borosilicate glass injection control bottle or low borosilicate glass injection bottle, plastic ampoule packaging form is also gradually used to pack less than 20ml sugar, salt water.
2. Requirements for packaging materials of injectable drugs
Chemical resistance and sealing properties of materials are particularly important for both large and small capacity injectable drug packaging. To this end, the State Food and Drug Administration has issued a number of large-capacity and small-capacity injection drug packaging standards for quality control. The product standard for low borosilicate glass controlled injection bottles, the standard number is YBB00302002, the product standard for sodium-calcium glass molded injection bottles, the product standard for low borosilicate glass molded injection bottles, the standard number is YBB00312002, and the product standard for low borosilicate glass molded injection bottles, the standard number isYBB00322003, low borosilicate glass ampoule product standard, the standard number is YBB00332002, sodium calcium glass control injection bottle product standard,YBB00332003, low borosilicate glass infusion bottle product standard, the standard number is YBB00012004, sodium calcium glass infusion bottle product standard, The standard is YBB00032005, high borosilicate glass tube injection bottle product standard Standard: YBB00292005-1 Product standard for neutral borosilicate glass Tube injection bottles: YBB00292005-2 The product standard for neutral borosilicate glass ampoule (No. YBB00322005-2); the product standard for neutral borosilicate glass infusion bottle (No. YBB00022005-2); The product standard for neutral borosilicate glass molded injection bottle (No. YBB00062005-2); the product standard for low density polyethylene infusion bottle (No. Standard number is YBB00012002 infusion bottle, pp product standard, the standard number for YBB00022002, three-tier co-extrusion infusion with membrane (|), bag of product standards, Y standard number is BB00102005, five layers co-extrusion infusion with film {1), bag of product standards, standards for YBB001 12005.
Iii. The packaging materials of injectable drugs should be investigated project
Under the premise that the packaging materials comply with the drug packaging standards, in order to investigate the impact of the drug packaging materials on the drug, strengthen the selection of packaging materials, it is appropriate to carry out the Compatibility test of drug packaging materials. The compatibility test of drug packaging materials and drugs refers to a test to investigate whether migration or adsorption occurs between drug packaging materials and drugs, thus affecting the quality of drugs. According to the State Food and Drug Administration issued drug packaging materials and drug compatibility test
The requirements of the guiding principles, the key items of plastic packaging materials are: water vapor, oxygen infiltration; Exhalation of moisture and volatile drugs; Transfer of fat-soluble drugs to plastics: adsorption of drugs by plastics; Solvents and plastics: additives in plastics and the effects of processing decomposition products on drugs; Migration of metal elements such as lead, cadmium, mercury and hexavalent chromium, as well as particles and sealing
The key investigation items of glass materials are:
Effect of release of alkaline ions in glass on pH of liquid; The release of harmful metal elements: different temperatures (especially freeze-drying), different pH conditions of glass strip: containing colorant light resistant glass is through some wavelengths of light, so that the drug decomposition.
