Tuesday, August 22, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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6.1.4 Equipment qualification

Design qualification (DQ): documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose.

The first element of the validation of new facilities, systems or equipment could be design qualification.

The compliance of the design with GTP should be demonstrated and documented.

Installation qualification (IQ): documented verification that the equipment or systems, as installed or modified, comply with the approved design, the manufacturer’s recommendations and/or user requirements

The protocol should include, but not be limited to the following:

a)   verify that all items of- equipment / facility under the requirements in the purchase order ;

b)  verify the location and- environmental conditions of the equipment / installation are correct according to the manufacturer's recommendations and internal;

c)   verify that these items are installed in accordance with internal specifications and manufacturer correctly identify;

d)  verify that the connection of electricity, water, steam, pressure, vacuum, etc., are necessary and that their operating ranges are appropriate for the proper functioning of the installation;

e)   verify that the operation of various items of equipment / installation once connected to the mains and put into operation is correct

f)   dentify action items that require calibration. Check for appropriate calibration certificates and program and procedure for periodic calibration;

g)   check for instructions for use and cleaning of equipment / manufacturer manual and log book of operations of the unit / installation;

h)  verify the existence of instructions for performing preventive maintenance.

Operational qualification (OQ): documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges

Operational qualification (OQ) should follow Installation qualification. The protocol should include, but not be limited to the following:

 

a) tests that have been developed from knowledge of processes, systems and equipment;

b) tests to include a condition or a set of conditions encompassing upper and lower operating limits, sometimes referred to as ‘worst case’ conditions;

c) identification of critical operating variables, tests performed, alarms, security devices and acceptance criteria.

The completion of a successful Operational qualification should allow the finalisation of calibration, operating and cleaning procedures, operator training and preventative maintenance requirements. It should permit a formal ‘release’ of the facilities, systems and equipment.

Performance qualification (PQ): documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method and specifications.

Performance qualification (PQ) should follow successful completion of Installation qualification and Operational qualification. Although PQ is described as a separate activity, it may in some cases be appropriate to perform it in conjunction with OQ.

The protocol should include, but not be limited to the following:

a)     tests, using production materials, qualified substitutes or simulated product, that have been developed from knowledge of the process and the facilities, systems or equipment;

b)    tests to include a condition or set of conditions encompassing upper and lower operating limits;

c)     process description or reference to protocol development and / or conditioning to validate;

d)    list of equipment involved;

e)     critical parameters and operating ranges;

f)     reference of the procedures involved;

g)     description of the tests to be performed, or control variables, sample taking, time and reference method sampling and analytical methods;

h)    acceptance criteria.

 

 

 

 

Qualification of established (in-use) facilities, systems and equipment

 

Evidence should be available to support and verify the operating parameters and limits for the critical variables of the operating equipment. Additionally, the calibration, cleaning, preventative maintenance, operating procedures and operator training procedures and records should be documented.

6.1.5Clean Rooms and Laminar Flow Hoods Qualification

Following the steps described in the Equipment Qualification paragraph, the tests to be carried out for the Clean Rooms will include at least:

a)     Flow and rate of renewals per hour: the speed and rate of renewals per hour according to specified will be checked;

b)    Absolute filters Integrity: the grade of sealing of the filters and the absence of leaks in the filter material will be checked;

c)     Particle counting: the total count of airborne particles (viable or not) will be checked according to specifications;

d)    Temperature / relative humidity: the temperature and relative humidity will be recorded during the test and will be checked according to specifications;

e)     Differential pressure: the pressure differential between the different areas will be checked according to specifications;

f)     Recovery test (normally tested for A and B classified clean rooms): the time required for a clean room to recover the specified classification after an out of specifications will be checked.

 

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Following the steps described in the Equipment Qualification paragraph, the tests to be carried out for the Laminar Flow Hoods will include at least:

a)     Speed and uniformity of the Air: the average speed meets the specified acceptance criteria and that there is uniformity will be checked;

b)    Absolute filters Integrity: the grade of sealing of the filters and the absence of leaks in the filter material will be checked;

c)     Particle counting: the total count of airborne particles (viable or not) will be checked according to specifications;

d)    Electronic test: all the operating controls will be checked (light, UV light, fan) and alarms;

e)     Smoke Test (for biological safety cabinets).The test objective is to study the behavior of air inside and outside the cabin with the help of a smoke generator.

 

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Diccionario - Ver diccionario detallado

Traducir cualquier sitio web

·Onet.pl-polaco

·Telegraph.co.uk-United Kingdom

·Berlingske.dk-Denmark

·Tom.com-China

·Sueddeutsche.de-Germany

·Los Angeles Times–United Kingdom

·Zamalek Fans-árabe

·OneIndia- India

·G1 Globo-Brasil

·The Washington Post– United States

·USA Today-United States

·Komika Magasin-sueco

All these tests should be performed at least in an ‘at rest’ situation. Additionally, in both cases the particle counting test should be performed also in an ‘in operation’ situation. 

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