In-House Testing

The Na—S system is expected to provide significant iacreases ia energy density for sateUite battery systems (69). In-house testing of Na—S cells designed to simulate midaltitude (MAO) and geosynchronous orbits (GEO) demonstrated over 6450 and over 1400 cycles, respectively. 

The bearing insulation is thus determined by the manufacturer while checking the shaft voltage at the works. This forms a routine in-house test for all HT and large LT motors. 

Special coverage of impulse testing of resin-rich formed coils and their in-house testing requirements is given. 

IVDs developed for use at a single site and offered commercially only at that site are considered laboratory testing services, in-house tests, or so-called "home brew" tests. These have historically been a widely used practice for test development, and a broad menu of tests is available in this mode. These tests are subject to CLIA regulation. If the test is performed by using commercially prepared and purchased active ingredients (so-called analytic specific reagents or ASRs), FDA does impose requirements on both the... 

Firm 1 - Very Large. Very large in-house testing facilities, about 50% TSCA-related in-house, about 50% contracted out. 

Firm 3 - Medium. In-house testing facilities for chemical and physical properties, not toxicology. 

AALAC certified laboratory. In-housing testing included acute, subacute, and subchronic oral, dermal and inhalation studies and specialty reproductive, behavioural, haematological and renal function toxicity studies. Preparation of risk assessment, submissions and presentations to regulatory agencies and trade association. 

In-house developed tests Clinical labs No Inspection by HCFA of use of in-house test in the clinical lab site Same as HCFA if state has deemed status... 

The major problem in testing today is designing tests which measure the desired property tests that predict failure, rupture, etc., with confidence. There are many in-house tests, tests developed by a particular company to measure a specific property, which may relate to tests already accepted by the ASTM. However, results of these in-house tests should not be directly compared with results derived from other test methods. 

Because of the cost and time required for extensive in-house testing, the trend today is to have most of the quality control tests done by the supplier. The supplier then provides a certified test report to the customer with shipment of the product. The test program that is used by the supplier, internal controls, etc., are usually verified and approved by the customer on a periodic basis, such as once per year. The approval tests are used to determine the adequacy of the particular materials in question and the production methods that will be employed. The tests that are done with every lot and submitted on delivery usually are made to ascertain the consistency of the product from lot to lot. 

A commercially available RIA for determination of free anti-insulin antibodies (CIS bio international) was used for method comparison with insulin tracer binding test for Type I diabetic patients. The CIS test uses a 125I-porcine insulin tracer for insulin antibody determination. Linear regression analysis yielded a correlation coefficient of 0.94 for human insulin antibodies. The absolute binding values were 10-15 % lower in the commercial test than in the in-house test. 

The purchase of a new CDS system should be a formal selection process to see if an application matches the main requirements of the URS. The outhne tests can be used to screen and select the system an in-house test can be an option if there is sufficient time and resources to do this. A selection report wonld be the outcome of this phase of the work and would form part of the supporting evidence for the CDS validation. This activity essentially links the URS to the suppher functional specification. 

However, correct labelling requires the knowledge of the concentration of the allergens and their behaviour during processing. In addition, the assessment of compliance with labelling requires suitable analytical procedures, which should be validated either by an internationally accepted in-house testing protocol or by a collaborative study. 

The present state of development is the completion of several third generation production units for outside evaluation by qualified interested institutions and users. In house testing and development of larger capacity units is continuing at an increasing rate. 

The brine shrimp test (BST), the piscidal activity against Artemia salina, is related to antitumor activity and is recommended by the National Cancer Institute (NCI) as an in-house test for promising antitumor compounds [45-47], (-)-Sesamin (enantiomer of 43) and 16 showed activity against BST [48,49], Compound 16 had an ichtyotoxic effect on guppies and strongly inhibited swimming activity [50], (-P)-Tsugacetal (50) showed weak activity in the BST [51],... 

Various small scale test units and procedures are available to determine slurry characteristics and suitability for a particular application. Buchner funnel, and vacuum leaf test units can be purchased or rented fi om vendors to perform in-house tests, or one can have tests conducted at the vendor s facility. Pilot testing on the actual equipment would be the optimum with a rental unit in the plant. In either case, slurry integrity must be maintained to ensure accurate filtration data. 

Apart from the tests defined in the standards, a number of in-house test methods exist. 

In-house testing requirement None Specimen preparation Specimen processing required... 

Lower acyclic alcohols such as butanol inhibited tyrosinase at very high concentrations [90], but the activity of higher, straight-chain alcohols had not been previously reported. In our in-house tests, both octanol (66) and decanol (67) showed weaker inhibitory activity than citronellol (56) (Table 3) but were much more active than lower alcohols [90]. From these results, the length of the alkyl chain appears to be the most critical factor for the attainment of significant activity. The addition of pendant methyl groups appears to enhance the activity. 

Depending on customer requirements, constant verification of a filled material s properties may be required. This responsibility may to some extent be reduced by the use of customer-certified precompounded materials from approved suppliers. Otherwise, particularly when fillers are added to resin near the press, in-house testing may require trained support staff using standardized, certified testing equipment and methods, and additional quality certification procedures. 

Stage 3 - Development The actual design and development of the new product. Stage 3 witnesses the implementatiOTi of the development plan and the physical development of the product Lab tests, in-house tests, or alpha tests ensure that the product meets requirements under controlled conditions. The deliverable at the end of stage 3 is a prototype product that has been lab tested and partially tested with the customer. 

This Subpart discusses where alcohol tests can take place and what forms and devices are used for testing. If you want to set up an in-house testing site, read this Subpart first. 

Once a single system has been chosen, it should be tested in-house for up to a month (dependent on the complexity of the tasks it should undertake) to confirm that it is a suitable choice. Here the opportunity for all users to have hands-on access to the system must be encouraged. This in-house testing will usually entail the purchase of the license of a specified time from the LIMS vendor. If the evaluation is... 

Quality assurance procedures by the manufacturers of the bonding agents should be at a level that reliance can be placed on their test certification. This can only be ascertained by inspection of certification and comparison with in-house testing. 

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