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1、Basic Requirements Ease of UseObtain demonstration units for evaluation a salesperson can demonstrate for you, but it is important to use the instrument yourself. Try out the types of tests you expect to do in production and let one or more actual operators perform the tests. Ideally, very few steps
2、 should be necessary to get to the actual integrity test. The instrument should not require input of unnecessary parameters, and should give hints on fields with mandatory data entry or entry limits. AccuracyMake sure the instrument is accurate. Accuracy claims can vary from 3% to 10% and do sometim
3、es depend on the test type that is used. Compare also the lower accuracy boundaries; they can range from 0.02 mL/min to up to 1 mL/min. Accuracy can only be confirmed if it can be verified against a reference. There are calibrated references available for gas flow measurement ranges from roughly 1 m
4、L/min to 1000 mL/min. You can use those to verify the accuracy claims given by the instrument manufacturers. References for Bubble Point tests are not available and accuracy claims on those tests are only mathematical functions. Find out if the instrument offers safeguards to prevent false pass resu
5、lts (and false failures). There are methods available to assure that the differential pressure over the tested filter is not impaired by elevated pressure on the downstream side of the filter, or to prevent a pass result if the integrity test is run against a closed valve. SpeedCompare how quickly t
6、he units perform their functions, especially the functions you expect to use routinely. If you compare the test speed also compare if higher speed has an impact on test accuracy. Simple to ValidateWhich tools and resources the vendor provides to assure that the instrument will be successfully valida
7、ted. In addition to a published validation guide, you will want to know specifics about IQ, OQ and PQ procedures and services. According to the GAMP5 guideline, an integrity test instrument can usually be rated as Class 3. It is acceptable to use generic documents from the instrument manufacturer. S
8、uch documents and appropriate guideline for PQ should be available. Properly CalibratedFind out how the instrument is calibrated. An instrument should be calibrated against references of the units it reports. For integrity test instruments this should be a calibration with pressure and flow referenc
9、es to assure accurate results. What is the accuracy transfer ratio between the calibration reference and the instrument under calibration? Are proper calibration certificates issued? Calibration needs to be performed by trained personnel. Find out what calibration equipment, training or calibration
10、service is offered for your instrument by the vendor. Design An instrument that is made for use in pharmaceutical production will typically be used in a cleanroom. There should be no ventilation on the instrument and it should not generate particles. Check that the instrument is dust and splash-proo
11、f. Can the instrument be cleaned externally and internally by appropriate methods? What methods are used to avoid process liquid to drain back into the instrument? An internal diagnosis program can help to check the internal hardware and software in regular intervals. Find out if all critical compon
12、ents like sensors, valves, volumes and data are checked and what needs to be done in case of failures.USD 2235a(1)Selection GuideSelecting a Filter Integrity Test InstrumentSelecting a filter integrity test instrument can be a complex task. Several departments can ask for different requirements and
13、set different priorities on the same features on an instrument. Since most instruments that are available offer the most important types of filter integrity test procedures that are accepted by authorities, the instrument can be chosen independent of the filter or housing manufacturer.The required f
14、eatures of an integrity test instrument can be very different depending whether the instrument will be used independently to produce paper documentation, if the instrument will be linked to a network and produce electronic records, or if the instrument will be remotely controlled from process contro
15、l equipment.We have listed a sequence of tests to evaluate an integrity test instrument. To give you a better idea of which features are important for the different operation methods, we have listed the general requirements in the section “Basic Requirements”, the requirements for use of electronic
16、records in the section “Electronic Data Handling” and the requirements for remote control of the instrument in the section “Automation”.Basic Requirements ServiceWhat service structure does the instrument vendor have? It can be an advantage if the instrument can be calibrated and serviced on site. Shipping instruments back to the manufacturer is time consuming, expensive and risky. Find out if you can get a replacement instrument if your instrument needed to be repaired. Do
