Significance and Use
5.1 The purpose of these test methods is to define a procedure for evaluating the capability and effectiveness of cleaning agents to remove residues of a compound/product from surrogate surfaces (that is, coupons or beakers) of Materials of Construction. This test method also provides a procedure for determining the compatibility of cleaning agents with the Material of Construction prior to starting tests. Based on the outcome of the testing, suitable cleaning agents may be selected for further cleaning process development (see Guide D6361/D6361M).
5.2 The potential critical cleaning parameters related to the cleaning agent(s) under study may also be examined using these tests. Potentially critical cleaning parameters include cleaning agent concentration, temperature, time, pH, foaming, type and strength of ultrasonic energy or agitation (if used), and others. These parameters may be varied (for example, using Design of Experiments) to determine their potential optimal settings for actual use.
Scope
1.1 This test method covers a procedure for evaluating the effectiveness and capability of cleaning agents to remove contamination to the desired level. This includes removing drug residues from manufacturing equipment and residues from medical devices (Guide E3106), as well as systems for oxygen service.
1.2 The test coupons/beakers described in this standard provide a representative surface to which contamination can be applied and tested for the ability of a cleaning agent to remove it.
1.3 This test method is a laboratory scale approximation and the actual effectiveness of a particular cleaning agent depends upon the method (temperature, agitation, concentration, etc.) in which it is used and the characteristics of the article being cleaned, such as size, shape, and material. Final evaluation of the cleaning agent should include testing of actual products and cleaning processes.
1.4 Units—The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.
1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the safety of each compound on a case-by-case basis.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
