Quality control tests for containers, closures and secondary packaging materials., Lecture notes of Total Quality Management (TQM)

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QUALITY CONTROL TESTS FOR

CONTAINERS, CLOSURES AND

SECONDARY PACKING MATERIALS

- Packaging of material is an integral part of the pharmaceutical industry. It affects the

quality, stability and identification of drug products.

- Packaging provides:

a) Adequate degree of protection

b) Minimize loss of constituents

c) Compliance to deliver quality products.

Commonly used packaging material:

• Container- Glass, plastic, metal or paper
• Closure- cork, glass, plastic or metal.
• Carton
• Boxes

PACKING MATERIALS

Any material that is used for packaging of products for their distribution and sale is said to be the packing material. Two types of packing material: i. Primary packing material Comes in direct contact with the product e.g. bottles, vials, ampoules, tin, etc. ii. Secondary packing material Used to cover primary packs e.g. cartons, boxes, etc.

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QUALITY CONTROL TESTS FOR GLASS

. CONTAINERS

1. Powdered glass test:

Done to estimate the amount of alkali leached from the powdered glass, which usually happens at elevated temperatures. Sample containers are rinsed with purified water and dried. I The containers are grinded in a mortar to a fine powder and passed through sieve no. 20 and 50. I 10gm of the sample is washed with acetone and dried. I 50 ml of purified water is added to the dried sample and autoclaved at 121 °C for 30 mins and cooled and decanted. I

The temp, is maintained at 121 °C to 122°C for 60mins. I The containers are cooled and the liquids are combined and volume measured. I It is titrated with 0.01M HC1 using methyl red as an indicator. This test helps assess the glass’s hydrolytic resistance. Ensuring the quality and compatibility of packaging Materials is crucial for maintaining the integrity of pharmaceutical products during storage and distribution.

3. Arsenic test: This test is for glass containers intended for aqueous parenterals. The inner and outer surface of container is washed with fresh distilled water for 5 min (to remove residue). I Then similar steps are followed as performed in the

hydrolytic test, previously described, till obtaining the final combined solution. I 10ml from the final combined volume is pipetted out and to it 10 ml of HNO 3 is added and dried in an oven at 130°C. I 10ml of hydrogen molybdate is added and refluxed for 25 mins. I It is cooled and absorbance is measured at 840nm. I The absorbance of the test solution should be less This test ensures that glass containers used for aqueous parenteral products meet the required quality standards. If the absorbance exceeds the specified limit, it indicates a potential issue with arsenic leaching from the glass container. Proper testing helps ensure the safety and efficacy of pharmaceutical products.^7

QUALITY CONTROL TESTS FOR PLASTIC CONTAINERS FOR NON-PARENTERAL

PREPARATIONS

1. Leakage test: 10 containers are filled with water and fitted with intended closures. I They are kept inverted at room temperature for 24 hours. I The test is said to be passed if there is no sign of leakage from any container. 2.Collapsibility test: This test is applicable to containers which are to be squeezed in order to remove the contents.

11 A container by collapsing inward during use, yield at least 90% of its normal contents at the required rate of flow at ambient temperature. 3 Clarity of aqueous extract: A suitable container is taken at random, and unlabeled, unmarked and nonlaminated portions is selected. I These portions are cut into strips I The strips are washed free from extraneous matter by shaking them with at least two separate portions of distilled water for about 30 secs. I The processed sample is taken in to the flask, previously cleaned with chromic acid and rinsed with distilled water. I

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CONTROL TESTS FOR

CLOSURES

Preparation of sample:

• The closures are washed in 0.2% w/v of anionic surface active agents for 5 mins.
• Rinsed five times with distilled water and 200ml water is added.
• Subjected to autoclave at 119°C to 123°C for 20-30 mins covering with aluminum foil.
• Cooled and solution is separated from closures (Solution A). 1 1. Residue on evaporation:

• 50ml of Solution A is evaporated to dryness on a water bath and dried at 105°C.
  • The residue weighs not more than 4 mg. 2) Fragmentation test For closures for aqueous place a vol of water corresponding to the nominal vol minus 4 ml in each of 12 clean vials. ↓ | Close the vials with the ‘prepared closures & allow to stand for 16 hours. | For closures for dry preparations close 12 clean vials with the ‘prepared closures. | Using a hypodermic needle with an external diameter of 0.8 mm inject 1 ml of water into the vial and remove 1 ml of air. | Carry out this operation 4 times with new needle each time Pass the liquid in the vials through a filter with a pores size of 0.5 μm. | No. of fragments is NMT 10 except in the case of butyl rubber closures where the total no. of fragments is NMT 15.

5. stabilitytest: Pierced ten times with hypodermic needle I Immersed in 0.1% methylene blue solution and subjected to a pressure of about 27KPa I Restored to ATM pressure and made to stand for 30mins I Traces of colored solution should not be

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QC TEST FOR SECONDARY PACKAGING MATERIALS

The test pieces of paper and board are taken for test to be carried out in standard condition a) Temperature: 23C̊ ± 1C̊ b) Relative Humidity: 50% ± 2%

1. Moisture Content- All the substances will be measured at temperature specified for test. 2. Folding Endurance- Fold the test piece back and forth until rupture occurs. 3. Cobb’s test- Test for water absorbency.

QUALITY CONTROL TESTS FOR CARTONS

1. Compression:

• Used to assess the strength of erected package there by estimating the degree of protection that it confers on the contents.
• This is useful for products with no inherent strength in one plane or another. 2. Carton opening force: - The carton should spring open in to its original shape without a need for unreasonable force.
• If the carton does not spring open or buckles in on itself, it may cause problems on cartooning machine.

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