Closures evaluation test

Glass or plastic bottles that have plastic or aluminum closures are tested for removal torque. The removal torque represents the force required to remove the closure from the bottle. Closures are also evaluated to ensure that they have been properly appHed and that they are tamper evident. Crown closures are also evaluated to ensure proper appHcation. 

G.A. Birrer, J. Liu, J.M. Halas aud G.G. Nucera, Evaluation of a container closure iutegrity test model using visual inspection with confirmation by near infrared spectroscopic analysis, J. Pharm. Sci. Tech., 54, 373-382 (2000). 

Pikal, M. I, and Lang, J. E. (1978), Rubber closures as a source of haze in freeze-dried parenterals Test methodology for closure evaluation, J. Parent. Drug. Assoc., 32, 162-173. 

It should also be noted that closure evaluation can rarely be assessed by one simple test, as the seal or fit between components may change with time and the surrounding climatic conditions. Typical evaluation stages could involve ... 

Having discussed how egress can be measured under normal static conditions, closure efficiency may still be influenced by conditions associated with transportation and warehousing (see above). Actual or simulated warehousing and transportation tests may be advised as part of a pack-closure evaluation. 

C. J. Milano and L. Bailey. Evaluation of current compendial physiochemical test procedures for pharmaceutical elastomeric closures and development of an improved HPLC procedure. J. Parenter. Sci. Technol., 53, 202 (1999). 

The objectives of a teratology study (see Note 2) are to evaluate the effects of the test item on embryonic and fetal development when administered during the period of organogenesis, i.e., from uterine implantation to the closure of the hard palate (see Note 3)... 

Extractability tests prescribed by other regulatory agencies [FDA, Parenteral Drug Association (PDA)] for closures for drug packaging [69,70] are also limited to the amount of extractable residues or tests to evaluate the in vivo reaction of the extractable residue when the material fails in the in vitro tests. 

Preventative Action. This observation could have been avoided by establishing a stability testing program SOP that specifies batches that are to be entered into the annual stability program, including all container-closure systems, and that requires that all commercial container-closure systems be tested. The stability program must include an evaluation of degradants and impurities if it is intended to assess stability. Additionally, a product-specific stability protocol should have been developed that specified the methods to be used. 

To establish suitability, all four attributes must be evaluated and be shown to pose no concern to the drug product or to product performance. Suitability refers to the tests used for the initial qualification of the container closure system with regard to its intended use. The guidance defines what tests must be done to evaluate each of the attributes of suitability. 

Evaluating the integrity of the container can be done in several ways. Two of the most common tests are dye penetration and microbial ingress. Container closure systems stored in a dye solution and exposed to pressure and vacuum cycles are examined for dye leakage into the container. The microbial ingress is similar in fashion but determines the microbial contamination of the contents when soaked in a media contaminated with bacteria. Other quantitative tests that can be run are vacuum/pressure decay, helium mass spectrometry, and gas detection. 

Cork taint is a musty/moldy off-odor in wine. It is related to the cork stopper, a wine botde closure made from the bark of the cork oak (Quercus suher). In a correlation between sensory evaluation and chemical analysis, 2,4,6-trichloroanisole (TCA) has b n identified as a major impact component. In sensitivity tests of a group of trained wine judges, a geometric mean of the minimum detectable concentrations of TCA has been determined at 4.6 ng/L. 

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