Test Methods and Criteria

Two main standardisation issues can be identified. The two missions are different and they should be developed separately in order to avoid misunderstanding. 

Durability of Products. Standard test methods are also necessary to predict the durability of plastic products made with biodegradable polymers when in use, in order to verify if they can resist the severe environmental factors foimd during life cycle. Durability is of commercial interest and test methods are required to classify the products performances. 

It is important to note that biodegradability and durability are two different properties. The first is a property of polymers while the second is a property of a product. A product can be optimal for agricnltnral applications, offering the required commercial life and then a fast disappearance and still not be environmentally compatible becanse it is not biodegradable or is nnsafe. Conversley, a polymer shown to be compatible with the soil environment, conld tnrn ont not to be suitable for a given application because it is not stable under environmental conditions, or too persistent (because, for example, it is converted into mnlch films that are too thick). 

1 Biodegradability and Environmental Compatibility of Polymers for Soil Applications 

the meaning of two terms freqnently used erroneously as synonyms (even by the experts) must be clarified biodegradability and biodegradation. 

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BS476 Part 8 Test methods and criteria for the fire-resistance of elements of building... 

The application (or Type II DMF) should include a detailed description of the complete container closure system for the bulk drug substance as well as a description of the specific container, closure, all liners, inner seal, and desiccant (if any), and a description of the composition of each component. A reference to the appropriate indirect food additive regulation is typically considered sufficient to establish the safety of the materials of construction. The tests, methods, and criteria for the acceptance and release of each packaging component should be provided. Stability studies to establish a retest period for bulk drug substance in the proposed container closure system should be conducted with fillers or desiccant packs in place (if used). Smaller versions that simulate the actual container closure system may be used. 

During the preparation of hazardous drugs, use a ventilated cabinet to reduce the potential for occupational exposure. Performance test methods and criteria for BSCs may be found in Primary Containment for Biohazards Selection, Installation and Use of Biological Safety Cabinets, second edition, CDC/NIH, 2000. A current field certification label should be prominently displayed on the ventilated cabinet per NSF/ANSI49. 

Pharmaceutical sites will usually create a dedicated team of validation specialists to coordinate all validation activities. They should operate according to a validation master plan that has been developed using risk analysis to identify the most critical systems requiring validation/re-validation. Before validating a system or process, a written protocol should be prepared that describes the system, the critical aspects, the objectives, the test methods and the acceptance criteria that will be applied. A validation report should be prepared on completion of each protocol. 

The Scope of Accreditation and Consideration of Methods and Criteria for the Assessment of the Scope in Testing , ILAC G18 2002, International Laboratory Accreditation Cooperation (ILAC), Silverwater, Australia, 2002. 

In addition to assessing nonspecific adsorption with a simple system such as just described, it is recommended that postwash-cycle testing be performed with the same qualification methods and criteria used to evaluate new column... 

Part of the difficulty in interpreting and comparing the 5-LO literature is the plethora of test methods and activity criteria. As pointed out in the introduction, inhibition of product release from cells, often stimulated with A23187, has commonly been used to demonstrate 5-LO inhibition. However, this type of assay cannot be assumed to be diagnostic for 5-LO inhibition [28,29]. Only if specificity for 5-LO product generation and (ideally) activity in cell-free enzymes is also shown should mechanistic interpretations be made. 

The sterilizer utilization list and the following OQ test requirements summary will be utilized to determine the products assigned to the sterilizer that shall be subjected to the type and number of test function runs required to establish overall sterilizer qualification or validation. The test function subsections shall include test objectives, test methods and acceptance criteria, as follows. 

International Laboratory Accredidation Cooperation (ILAC) (2002), The scope of accreditation and consideration of methods and criteria for the assessment of the scope in testing, ILAC-G18, ILAC Technical Accreditation Issues Committee, available www. ilac.org. 

Validation protocols are required to describe the objective, methodology, and acceptance criteria for installation, operational, and performance qualifications. They are written to ensure test methods, and acceptance criteria are reviewed and approved before qualification of protocols. In practical terms, there are several stages for the production of protocols. First, an acceptable format needs to be agreed. No universal format exists for protocols, but to some extent, the type of equipment, the size of the project, and the personal preferences will dictate the protocol style. However, some norms have been established. Like other controlled documents, protocols are assigned unique reference numbers and revision numbers. They are titled and numbered on every page and have a particular place for approval signatures. Other common elements in protocols tend to be brief descriptions of the item being qualified and a clear statement of responsibilities. 

To establish safety and to ensure consistency, the complete chemical composition should be provided for every material used in the manufacture of a packaging component. Test results from appropriate qualification and characterization tests should be provided. Adequate information regarding the tests, methods, acceptance criteria, reference standards, and validation information should be also provided. 

Qualification or validation begins with a protocol or plan that describes fully the approach, including the scope, description of equipment, utilities, test methods, acceptance criteria, etc. The approved protocol is then executed by performing the requisite number of replicates as specified in the protocol and gathering the indicated data. The final step is the preparation and approval of a report containing the findings of the activity against the acceptance criteria found in the protocol. 

Test guidelines are developed by various national and international organizations. Table 12.4 lists the OECD and U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) guidelines. It also lists experimental conditions, analytical methods, and criteria for whether a chemical is considered to be biodegradable (pass) and non-biodegradable (fail), when applicable. 

Rationale for bracketing and matrixing Storage conditions Container orientations Test methods Acceptance criteria Retest/expiration dating period Storage conditions for different types of protocols Clinical trial material Registration stability Annual batches Postapproval changes Special studies Test Parameters... 

In cleaning applications and in uses resulting in discharges of effluent to the environment, the surfactant will be required to meet biodegradability criteria but test methods and biodegradability pass levels vary worldwide. 

The criteria in selecting and using the right flame-retardant system for a specific adhesive formulation can be broad and somewhat complex. Care must also be taken with regard to choosing the proper test method and determining the parameters of the test. Consultation with the flame-retardant suppliers is generally necessary to optimize this process. 

The specification serves to guide buyers it serves for comparison of batches to recommend analytical procedures for active ingredient or impurities to provide methods and criteria for identity of the active ingredient and to provide chemical and physical parameters as additional tests for judging the suitability of formulations. It ensures that the product is satisfactory for the use for which it was intended by requiring that the product possess defined chemical and physical characteristics that can be verified by test methods. 

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