Solution Of Pharmaceutical Packaging Materials

I. Introduction:

Pharmaceutical packaging materials are those used for packaging drugs, including packaging materials, containers and printed packaging materials that contact with drugs directly.

Packages of drugs include inner and outer packages and printed packaging materials, which shall be of good blocking, safety, processability and economy performance.

1. Inner package. It refers to packages contact with drugs directly, such as ampoule bottle, vials for injection, aluminum foil, etc. Inner packages shall guarantee quality of drugs during manufacturing, transportation, storage and use. In case of changes to inner packaging materials or containers (drug package materials) of drugs, stability test shall be performed according to material of selected drug package materials to verify compatibility between drug package materials and drugs.

2. Outer package. It refers to package except for inner packages. It is divided into medium package and large package from inside to outside. The outer package shall be those not easily broken based on characteristics of drugs to ensure quality of drugs in transportation, storage and use.

3. Printed packaging material. It refers to packaging material with specific form and printed contents, such as printed aluminum foil, label, instructions, box, etc.

II. Classification:

1. I-type drug package materials: package materials which contact with drugs and be used directly, such as plastic infusion bags or bottles, plastic bottles for solid or liquid medicines:

1) Medicinal butyl rubber stopper for infusion bottles;

2) PTP aluminum foil for drug packaging;

3) Medicinal PVC sheet;

4) Medicinal plastic composite hard sheet and composite film (bag);

5) Plastic infusion bottle (bag);

6) Plastic bottle for solid or liquid medicines;

7) Plastic bottle for eye drops;

8) Ointment tubes;

9) Spray valve of aerosol;

10) Aluminum-plastic composite cover of antibiotic vials

11) Other drug package materials that contact with drugs directly.

2. II-type drug package materials: package materials which contact with drugs directly and can be sterilized after easy cleaning, such as glass infusion bottles, rubber stopper of infusion bottles and glass oral solution bottles.

1) Medicinal glass tubes;

2) Glass infusion bottles;

3) Glass molded antibiotic vials;

4) Glass tube-formed antibiotic vials;

5) Glass molded oral liquid bottles;

6) Glass tube-formed oral liquid bottles;

7) Medicinal glass (yellow, white) bottles;

8) Ampoules;

9) Glass bottle of eye drops;

10) Natural rubber stopper of infusion bottles;

11) Natural rubber stopper of antibiotic vials;

12) Aerosol cans;

13) Rubber gasket (washer) of bottle cover;

14) Polyester film of infusion bottles;

15) Ceramic drug bottles;

16) Plastic ball shell of Chinese medicine pill;

17) Other drug package materials that contact with drugs but easy to clean and sterilize.

3. III-type drug package materials: package materials which may affect drug quality directly except for I and II types, such as aluminum cover of infusion bottles, aluminum-plastic composite cover, etc.

1) Aluminum (aluminum alloy) cover of antibiotic vials;

2) Aluminum (aluminum alloy) or aluminum-plastic composite cover of infusion bottles;

3) Aluminum (aluminum alloy) or aluminum-plastic composite cover of oral liquid bottles;

4) Other drug package materials that may affect drug quality directly except for those under management for II and III types.