Design acceptance tests

It is necessary to estabUsh a criterion for microbial death when considering a sterilization process. With respect to the individual cell, the irreversible cessation of all vital functions such as growth, reproduction, and in the case of vimses, inabiUty to attach and infect, is a most suitable criterion. On a practical level, it is necessary to estabUsh test criteria that permit a conclusion without having to observe individual microbial cells. The failure to reproduce in a suitable medium after incubation at optimum conditions for some acceptable time period is traditionally accepted as satisfactory proof of microbial death and, consequentiy, stetihty. The appHcation of such a testing method is, for practical purposes, however, not considered possible. The cultured article caimot be retrieved for subsequent use and the size of many items totally precludes practical culturing techniques. In order to design acceptable test procedures, the kinetics and thermodynamics of the sterilization process must be understood. 

These tests are used to evaluate the technical suitability of a prototype or a preproduction model. It is sometimes practical to integrate technical evaluation with operational evaluation when the earlier design-acceptance test demonstrates complete conformance. 

Bultzo, C., Turbomachinery Acceptance Testing for Conformance to Design Criteria and Overall Performance Evaluation, ASME Petroleum Division Conference, New Orleans, LA, September 14, 1972... 

When equipment or plant is taken out of service, either for maintenance or for repair, it should not be re-introduced into service without being subject to formal acceptance tests that are designed to verify that it meets your declared standard operating conditions. Your procedures need to provide for such activities and for records of the tests to be maintained. 

To accomplish this, you need to specify either in the quality plan or the documented procedures, the inspections and tests you intend to carry out to verify that the product meets specified requirements. In Part 2 Chapter 4 there is a description of a Design Verification Plan and this includes a specification of the tests and inspections to be performed on each production item as a means of ensuring that the qualified design standard is being maintained. This requires that you produce something like an Acceptance Test Plan which contains, as appropriate, some or all of the following ... 

Additional detailed information is available from the Cooling Tower Institute, including ATF-105 Acceptance Test Procedure for Water-Cooling Towers, STD-101 CTI Grades of Redwood Lumber [31], STD-102 Structural Design Data [70], and TSC-302 Cooling Tower Wood Maintenance [16],... 

Guy line anchors including expanding anchors, concrete deadmen, or any other approved techniques are acceptable. The soil condition may determine the most applicable type. Recommendations for anchor design and testing are as follows ... 

After obtaining the prototypes, tests must be made to determine the utility. Generally these include a short time destructive test to determine the strength and to check out the basic design. Another test that is done is to use the product in the projected environment with stress levels increased in a rational manner to make for an accelerated life test. Other tests may include consumer acceptance tests to determine what instructions in proper use are required, tests for potential safety hazards, electrical tests, self-extinguishing tests, and any others that the product requires. In the case of high risk products, the test program is continued even after the product enters service. 

Cmcial documentation needed in the development phase includes end-user manuals, a unit test summary report, a user acceptance test plan, results of the database design, results and methods employed in the source code evaluations, and a trace-ability analysis. A source code traceability analysis verifies that all code is linked to established specifications and established test procedures. 

In an expediently designed plant, one can expect to reach in the pressure range above 8 10-2 mbar a vapor velocity in the cross-section Fk of between 50 and 80 m/s (l/d = 2.5 to 5) However 90 m/s will be reached only, if the design uses special features, e. g. a funnellike connection between the chamber wall and the location of the valve, slow changes in the outline, and smooth surfaces without sharp edges or holes. It is also recommendable, to clarify the maximal amount of vapor transportable at several pressures in a plant specification, e. g. at pch = 1 mbar a minimum of 3 kg/h and at pch = 0.04 mbar a minimum of 25 g/ h flow of water vapor must be demonstrated during the acceptance test, while the condenser temperature is below -30 °C, respectively below -57 °C. Such measurements can be earned out practically with sufficient accuracy (see e. g. Fig. 2.19 and the related text). 

Meyers, G.E. "Design Criteria and Acceptance Test Specification for Blast Resistant Thermally Tempered Glass Glazing," Department of Defense Explosive Safety Seminar, Anaheim, CA, Aug 1986. 

DQ is performed by the supplier of the equipment or system at the supplier s factory as part of the factory acceptance test (FAT). IQ (based on site acceptance test—SAT), OQ, and PQ are performed on-site at the GMP facility. For a GMP manufacturing facility, the validation activities include the facility design, FTVAC system, environment control, laboratory and production equipment, water system, gases and utilities, cleaning, and analytical methods. Validation protocols (IQ, QQ, and PQ) are prepared for each item, listing all critical steps and acceptance criteria. Deviations are reviewed and resolved before the validation activity proceeds to the next phase. 

Following risk assessment, the next step is to draft a formal validation plan. This is a written plan that includes all the specific validation procedures, installation tasks, acceptance testing, documentation requirements, reviews and verification tasks that need to be followed for proper system validation. The plan should also define individual responsibilities for these tasks and include an expected timeline. The plan should be designed around the URS and take into account the risk assessment determinations performed earlier. 

The company or facility should make use of the services of an engineer knowledgeable and trained in fire protection. Ideally, a registered fire protection engineer should be available to review fire protection designs. Fire safety, loss prevention, or process safety engineers should assist in the analysis of hazards, selection of protection system specifications, approval of the system, and acceptance testing. 

Acceptance tests should be performed on all new or modified fire protection systems. The goal of the final acceptance test is to determine if the fire protection system performance meets the design specification. The installation contractor is responsible for the acceptance test and remains the owner of the fire protection system until the acceptance test has been successfully completed. 

The acceptance test for the water storage tank should follow the requirements of the design specification. 

As far as possible, systems existing in a production mode prior to the effective date of the GALP standards, as well as purchased systems, should be docmnented in the same way as systems developed in accordance with the EPA System Design and Development Guidance and Section 7.9.2 of the GALPs. Documentation relevant to certain phases of the system fife cycle, such as validation, change control, acceptance testing, and maintenance, should be similar for all systems. 

Expert systems can also be used off-line as advisory systems. If some leeway is left in the process specifications, operators can even be instructed to make simple variations in the process. Hajicek developed an expert system for troubleshooting injection molding, which was designed to be used by operators to adjust controls as needed whenever part quality suffered [20], These expert systems do not necessarily plan an entire cycle. As we will see in the section on in-process control, however, they can be used to do so. There are even specifications that include rules for altering the cure cycle in response to the results of quality acceptance tests such as flow and volatiles, a primitive set of heuristics. 

At the time of completion of an installation, the water and air conditions and the loads may not be exactly the same as those of the design specification. Acceptance tests performed then must be analyzed to determine if the performance is equivalent to that under the design specifications. Such tests usually are performed in accordance with recommendations of the Cooling Tower Institute. 

How the integrity of quality-related critical process parameters and data will be maintained throughout design, development, and acceptance testing and within the system in its operational use... 

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