Testing , method transfer

Standard reference materials provide a necessary but insufficient means for achieving accuracy and measurement compatibiUty on a national or international scale. Good test methods, good laboratory practices, well-qualified personnel, and proper intralaboratory and intedaboratory quaUty assurance procedures ate equally important. A systems approach to measurement compatibiUty is ikustrated in Figure 2. The function of each level is to transfer accuracy to the level below and to help provide traceabiUty to the level above. Thus traversing the hierarchy from bottom to top increases accuracy at the expense of measurement efficiency. 

Method Transfer. Method transfer involves the implementation of a method developed at another laboratory. Typically the method is prepared in an analytical R D department and then transferred to quahty control at the plant. Method transfer demonstrates that the test method, as mn at the plant, provides results equivalent to that reported in R D. A vaUdated method containing documentation eases the transfer process by providing the recipient lab with detailed method instmctions, accuracy and precision, limits of detection, quantitation, and linearity. 

Fastness to Crocking. Crocking is defined as the transfer of color from the surface of a dyed fabric to another surface by mbbing. AATCC test method no. 8 is a method by which a colored test fabric swatch is fastened to the base of a Crockmeter and mbbed against a white crock test cloth under controlled conditions. Color transfer to the white cloth is evaluated by comparison with the AATCC Chromatic Transference Scale. A similar method, AATCC 116, uses a Rotary Vertical Crockmeter, which requires a smaller area of test fabric than the Crockmeter. 

While the carbon dioxide/caiistic test method has become accepted, one should use the results with caution. The chemical reaction masks the effect of physical absorption, and the relative values in the table may not hold for other cases, especially distillation applications where much of the resistance to mass transfer is in the gas phase. Background on this combination of physical and chemical absorption may Be found earher in the present section, under Absorption with Chemical Reaction. ... 

The considerations applicable to corrosion test methods also apply to tests for inhibited products. The metals and alloys used, their surface preparation, the temperature, flow rate, composition of the test medium, the presence of heat transfer, and so on, must all be relevant to the proposed use of the inhibited product. As with other test methods there are those tests... 

D 2688 1983 Test method for corrosivity of water in the absence of heat transfer (weight loss methods)... 

Test method for corrosion of cast aluminium alloys in engine coolants under heat-transfer conditions... 

On arrival at the creamery the milk is tested and transferred to bulk-storage tanks, which may hold up to 150 t each. These will be heavily insulated and may have some method of cooling, so as to keep the milk down to 4°C until it passes into the processing line. 

Drug substance/drug product purity, potency, and other testing Drug substance/drug product stability testing Method development, validation, and transfer Drug product formulation development... 

All these systems have been pnt into mathematical formnlae that can be transferred to each other, bnt possibly different measuring conditions mnst be taken into account. The British Standards Institnte and the International Standards Organization have edited general gnidance and test methods for the assessment of the colors of foods. ... 

For any new excipients, APIs or drug products (where new does not necessarily mean novel, but new to the receiving site) there are additional testing criteria, e.g. supplier audits, third-party contract laboratory audits, analytical method transfers, sample management/tracking, etc. For those key excipients, where there is on-site historical experience, it still behoves both parties to check whether the local grade/supplier used by the CMO is equivalent to that used by the supplier (Worsham, 2010). There are many examples of differences in excipient physical properties, e.g. particle size, which have been attributed to different excipient sources that could ultimately impact on the performance of those excipients in formulated products (Frattini and Simioni, 1984 Dansereau and Peck, 1987 Phadke et al., 1994 Lin and Peck, 1994). 

This is a similar approach to that articulated by USP, where transfer waivers can be utilised if the receiving site is considered to be qualified to use the method(s), without comparison or generation of inter-laboratory comparative data. The different types of testing associated with the different types of method transfer, together with acceptance criteria are summarised in Table 5 (Raska et al., 2010). 

Table 5. Typical Analytical Testing and Acceptance Criteria for Different Types of Method Transfer (adapted from Raska et al., 2012)...

In another test method (ASTM D4055), pentane-insoluble materials above 0.8 xm in size can be determined. In the test method, a sample of oil is mixed with pentane in a volumetric flask, and the oil solution is Altered through a 0.8- xm membrane filter. The flask, funnel, and filter are washed with pentane to transfer the particulates completely onto the filter, which is then dried and weighed to give the yield of pentane-insoluble materials. 

This test method can be used in the commercial transfer of petroleum coke to determine whether that lot of coke meets specifications. This method can... 

---