Sampling systems, certification

Where is it possible or desirable to locate the near-infrared analyzer modnle What hazardous area certification requirements apply to both analyzer and sampling system ... 

Once the data are available, certification of sampling systems as unbiased, without qualification, is insufficient, and certification should also be accompanied by a statement of (1) the mean levels of each variable constituent that prevailed during conduct of the test, (2) the nominal sizing of the coal, and (3) some indication of the preparation (washing) to which the coal has been subjected, since these influence the sampling constants and may affect the magnitude of bias observed. 

The calorimetry certification program will continue to use the Cutler Hammer recording calorimeter that has been the workhorse of the existing IGT program. This has been supplemented for the current program expansion by the addition of a third calorimeter and constraction of an automated, six-port gas manifold sampling system to permit unattended measurements on batches of five cylinders. 

The entire quality system shall be assessed at a minimum of once every three years. The audit plan for a supplier has to cover all requirements, all sites, all locations, all operations, all functions, all customers, all processes, all procedures at least once in a three-year cycle, unless it is an upgrade certification (see clause 4.6). Hence the sample of operations taken on each audit has to cover at least Veth of the whole. 

EC verification provides an alternative to the model of establishing a certified production QA system. Independent testing of either all devices, or a statistically representative sample of each batch, is conducted by or on behalf of the Notified Body, which then issues a certificate of conformity for the tests conducted. This is not a popular option due to the costs involved. The procedure is not capable of providing adequate assurance as to the sterility of devices. Instead, an assurance of sterility must be based on the application of a production QA system to the sterilisation process. 

For standard or proprietary polymer additive blends there is the need for analytical certification of the components. Blend technology has been developed for two- to six-component polymer additive blend systems, with certified analytical results [81]. Finally, there exist physical collections of reference additive samples, both public [82] and proprietary. The Dutch Food Inspection Service reference collection comprises 100 of the most important additives used in food contact plastics [83-85]. Reference compounds of a broad range of additives used in commercial plastics and rubber formulations are generally also available from the major additive manufacturers. These additive samples can be used as reference or calibration standards for chromatographic or spectroscopic analysis. DSM Plastics Reference Collection of Additives comprises over 1400 samples. 

Kohnstamm encountered the kinds of delays that often plague new systems and several times had to push back the initial shipping date. What it found most trying, perhaps because it was beyond its control, were the extensive delays in receiving certificates from the Board. The Board s procedure was cumbersome and slow. Kohnstamm sent certificates and samples to the Board in Washington where they were checked for form and completeness. These went next to the Bureau of Chemistry s New York laboratory where a single chemist, in addition to other duties, repeated all the tests the firm had done on the dye to see if it indeed matched the results and quality claimed. The chemist then sent his report to Hesse. If Hesse approved it, he informed the Board, who only then issued a certificate and assigned a lot number (52, 53). In exasperation, the company advertised in May that it would ship all orders on hand on June 1 "unless the US laboratory fails to check up our certifications. . . promptly, which has been the case up to now, but we have every reason to believe they will do more expeditious work on them in the future" (54). 

Sampling is just the beginning of the analytical process. On the way from sampling to the test report a lot of different requirements for high quality measurements have to be considered. There are external quality assurance requirements on the quality management system (e.g. accreditation, certification, GLP), internal quality assurance tools (e.g. method validation, the use of certified reference material, control charts) and external quality assurance measures (e.g. interlaboratoiy tests). 

Electrical safety. Most common commercial instruments have been certified for electrical safety by an organization such as UL (Underwriters Laboratory), CE, or CSA (Canadian Standards Association). However, certain less common instruments or custom-built instruments may have to go through a certification process at the time of installation. Certification required for electrical safety may take time to complete. A protective shield or casing may be required for automated systems with robotic arms for sample manipulation, to protect operators. 

Raw materials must always be approved by the Quality Unit before use by production. Each lot of raw material should be sampled and the laboratory should perform at least an identity test in addition to verifying from the supplier Certificate of Analysis (COA) that the lot test results conform to the excipient manufacturer s specification. Upon approval, the status of the lot is changed from unapproved or quarantine to approved or available. The raw material lot status can be identified by use of approval labels on the container or pallet, movement of the raw material lot to the approved section of the warehouse, or by changing the lot status in a computerized inventory system. 

A comprehensive report should be issued upon completion of the test procedures, which should include all values measured for compliance, a listing of all test equipment, calculations, conversions, and all appropriate statistical justification along with comments pertaining to system function and operation. A dated test-completion or certification sticker should be affixed to the LAP unit referring any examining authority to the completed test report. All reports should include floor plans or maps of the clean space, which identify sample locations, probe heights. 

Certificate of analysis for finished product Type of container and pack size Batch numbering system Pau ticulars of product as specified in Sections Cl, C2, C4 and C5 of the application form for product licence (if different from that submitted previously) Product sample... 

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