Inteligencia emocional en el ámbito laboral

The OQ is to verify that the specified components of the HVAC system operates as specified and are in agreement with the acceptance criteria and critical systems.

The HVAC system components described in the final design and specifications or authorized changes to the design or specification needs to be qualified to demonstrate their adequate operation. In general, the Operation Qualification scope is to test the individual components of the system such as air-handling unit, ductwork, blowers and others.

Operational Qualification (OQ) protocol No OQP\VD\01\R00 shall be generated; the following qualification tests will be included in the OQ protocol and protocol must be prepared according to SOP-VD-011.

The final performance (i.e. performance qualification) of the system in terms of environmental quality, such as temperature, humidity airborne cleanliness (viable and non-viable), can be assessed only under dynamic conditions whether real or simulated and when the other components of the environmental control system are in place.

Prerequisites: The following list of actions must be completed prior to the beginning of execution of operation qualification protocol, with reference to the validation master plan:

 Installation qualification must be completed.

 All critical punch-list items from IQ must have been resolved and completed.

 All related SOP’s for operation and maintenance of HVAC must have been approved.

 Training in pertinent SOP’s for operation of HVAC & sterile area facility must be completed and documented from all concern departments and persons.

The following qualification activities for the OQ must be performed. Successful qualification execution of the activities listed will satisfy the OQ effort for HVAC system.

i. Verification Of Critical Instrument Calibration.

i.1 Instrument that are used to operational decisions for the HVAC system or which provide data that is recorded as part of production or maintenance records, are considered to be as critical instruments. Critical instruments should be verified to be in a current state of calibration. Critical instrument for HVAC system may include:

i.1.1. Pressure gauges (including differential pressure (ΔP) gauges).

i.1.2. Pressure sensor/transmitter/display systems (including ΔP).

i.1.3. Thermometers.

i.1.4. Temperature sensor/transmitter/display systems.

i.1.5. Relative humidity (RH) sensor/transmitter/display systems.

i.1.6. Flow meters (air and liquid) i.1.7. Data loggers/Recorders.

ii. Operational Procedure Compliance Test.

ii.1 A final draft or higher standard operating procedure (SOP) for the operation of the equipment comprising the HVAC system should be verified to be available.

(Examples of the SOPs that will be needed):

ii.1.1. SOP # XXX -001 : Operation and Maintenance of the Air Handing Unit ii.1.2. SOP #XXX -002 : Calibration Procedure of Temperature Probe ii.1.3. SOP # XXX -003 : Calibration Procedure of Humidity Probe ii.1.4. SOP # XXX -004 : Calibration Procedure of Static Pressure Probe

ii.2 Personnel operating the system or its individual components during OQ execution should be verified and to have been trained to the referenced SOP(s).

ii.3 SOP availability and operator training should be documented in the protocol test data sheets for this section.

ii.4 Scrutiny of SOP and training of personnel is essentially required in order to assure the availability of written operating procedures that can be verified to complete and accurate, or can be highlighted to make them changes during normal function and/or cycle testing and which can be finalized and approved prior to Performance Qualification (PQ) execution.

ii.5 Operational procedure ensures that the outcome of the individual OQ tests are not distorted by operating the system in a manner that differs significantly from the intended methodology during standard operation.

iii. HVAC start-up and shutdown operation test.

iii.1 To test the start-up and shutdown sequence of the air handling units are as controlled by the controlled system.

iii.2 The testing procedure is designed as a function of the control system. The protocol should outline the sequence to be followed and the devices that intervene in the system.

iii.3 Start-up and shutdown sequence must be recorded, which may provide additional comments or description or unexpected test results.

iii.4 The air-handling unit start-up and shutdown sequence must operates in accordance with the design specifications and accordance to the predetermined limit accordance to URS.

iv. Loss of Utility Test.

iv.1 HVAC system response to the loss of support utilities should be investigated.

iv.2 Response to the loss of electrical power must be tested in all cases, which should include retention of critical data as well as equipment/system response.

iv.3 Equipment/System responses to the loss of other utilities should be documented to ensure that proper protection is provided in the equipment/system design.

iv.4 Loss of electrical power must not result in loss of critical parameters data.

iv.5 Equipment/system behavior upon loss or upon resumption of a given utility must be in accordance with available documentation.

iv.6 HVAC systems utility may supply multiple areas; it is very critical that execution will not interfere with other ongoing operations. Support utilities for HVAC systems include:

iv.6.1. Electrical Power iv.6.2. Clean Steam iv.6.3. Compressed Air

iv.6.4. Hot/Cold water (for heat exchange)

iv.6.5. Chilled water and glycol (for heat exchange)

v. Airflow velocities and patterns

v.1 In a unidirectional airflow area, usually over a sterile product filling lines, it is important that the air flowing through the critical area has a velocity which is sufficient to produce unidirectional flow and to sweep particulate matter away from the process.

v.2 Airflow velocity should be determined for each HEPA filter, as the average of multiple measures taken at various locations across a plane parallel to and not more than 6inches from filter face.

vi. Clean Room HEPA Filter leak test.

vi.1 HEPA filters shall be replaced after five or ten years, as applicable, from the date of original certification at a DOE filter test facility, if the manufacturing date is not available. HEPA filter systems are designed and installed so the system can be quantitatively leak tested.

vi.2 The injection port and sampling ports must be of sufficient size (nominal ½ inch in diameter) for the insertion of the output line from the aerosol generator or photometer probe.

vi.3 Filter leak test should be performed according to the test procedure as per ISO 14644 which will confirm the filter media and filter seal integrity.

vii. Audit of Air Balance reports.

vii.1 Airflow from AHU to each individual supply air location within the area must be adjusted to within specified tolerances of design flow. This is necessary to achieve proper airflow patterns within the area serviced by the system.

vii.2 Air change in the room must be not less than 20air changes per hour.

vii.3 The return airflow to the AHU must also be adjusted in order to produce the specified pressure differential between individual areas served by the system and adjacent areas.

vii.4 The air balance reports should be reviewed for the following:

vii.4.1. SOP for Availability of air balancing procedures.

vii.4.2. Conformance of post-balanced airflow to design.

vii.4.3. Availability of calibration certificate for instruments used during balancing.

vii.4.4. Conformance of static pressures throughout the system to design.

vii.4.5. Room air changes rates.

vii.4.6. Room/area differential pressures.

vii.4.7. Test technician qualifications.

viii. Air pattern Test (Airflow visualization)

viii.1 It is important (Unidirectional flow area) that air flows through the critical area in a smooth pattern without disturbances or eddies which would prevent particulate matter from being swept out of the area by the airflow or cause less clean air to be brought into the cleaner area.

viii.2 Air pattern testing shall be conducted in critical rooms/areas to demonstrate airflow patterns from HEPA through areas/levels of product exposure.

viii.3 Air pattern testing shall also be designed to verify airflows from high-pressure areas (clean) towards lower pressure areas (less clean).

viii.4 All air patterns shall be verified by visually observing airflow with smoke sticks, vapor generators, or other suitable means.

viii.5 Air pattern testing must be recorded via videotaping.

viii.6 Airflow pattern testing should be done in both static and dynamic conditions.

viii.7 Influence of personnel on the airflow pattern during normal operations (sterile filling machine set-up, aseptic connection of sterile transfer lines and interventions) should be included in the studies.

viii.8 An audit may be performed if the documentation for air pattern testing is available and complete. If the documentation is found not satisfactory then the “test”

procedure must be performed.

ix. Temperature and Relative Humidity Monitoring

ix.1 Temperature and relative humidity (RH) within the rooms/areas served by the HVAC system is controlled for personnel comfort and process interactions (i.e. too low an RH contributes to static formation; too high may hinder drying steps).

ix.2 Temperature and RH testing should be performed to verify the ability of the HVAC system to control and maintain these parameters in all rooms and areas.

ix.3 Temperature and relative humidity measurements shall be taken in each of the rooms or areas with the environment in an at-rest condition and operational conditions.

ix.4 The temperature and RH measurements shall be collected in each room or area over a twenty-four (24) hour period using independent calibrated measuring devices.

ix.5 Measurement must be taken in the four corners and the approximate center of each room or area at a height of approximately 3feet from the floor.

ix.6 Measurement must be performed at least once in each of three consecutive eight-hour time periods.

ix.7 Control system temperature and RH readings should be recorded for each room simultaneously with taking the independent measurements.

ix.8 Available control system temperature and RH archives for the test period should be attached to the protocol.

ix.9 Outside temperature and humidity should also be measured and recorded once for each set of measurements.

ix.10 An audit may be performed if the documentation for Temperature and Relative humidity monitoring is available and complete. If documentation is found not be satisfactory then the “Test” procedure must be performed.

x. Clean room pressurization test (also differential pressures)

x.1 To maintain air quality in critical and controlled areas, it is important that any airflow that occurs between adjacent areas, which have different classification levels, must be from the cleaner area to the less clean area (i.e. from a class 5 area to a class 8 area). This is accomplished by maintaining the air pressure in the cleaner area at a slightly higher level than an air pressure in the less clean area.

x.2 Airflow direction (i.e. in some solid dosage facilities) is designed to create conditions that contain product and minimize cross contamination. This is accomplished by maintaining the air pressure in a common area at a slightly higher or lower level than the air pressure in the adjacent areas of different classifications or cleanliness level (same classification).

x.3 Differential pressure/airflow directional testing shall be conducted to verify the ability of the HVAC system to maintain plant pressurization (positive and negative) between adjacent areas as per the design specifications. This monitoring should be performed routinely and action level should be established in the monitoring program.

x.4 Differential pressure readings/measurements should be recorded using existing, (calibrated) installed system instrumentation. In the absence of such instrumentation, an independent calibrated ∆P gauge or inclined manometer with an appropriate range may be used. The recording of differential pressure measurements shall be conducted once a day for three (3) days in order to demonstrate stability.

x.5 An audit may be performed if the documentation for the Differential Air Pressure and Direction Test is available and complete. If documentation is found not satisfactory then the “Test” procedure must be performed.

x.6 ∆P between any room and the main corridor must be within the tabulated defined range, which ensures that the ∆P between two adjacent rooms, which have same/different classification levels, is not less than 12.5pa. The supply and return air volumes should conform with the range specified. Pressure differential between rooms should be maintained as indicated in the specifications

xi. Clean room non-viable particulate count test

xi.1 The non-viable particulate test shall be performed to verify the effectiveness of the environmental filters in minimizing and in effectively removing non-viable particulates from critical and controlled areas, which may be present.

xi.2 Non-viable particulate samples shall be taken in each room or area in “at-rest”

conditions.

xi.3 Non-viable particulate samples shall be taken using an independent calibrated particle sampler and recording instrument.

xi.4 Each sample location within the room/area shall be sampled to determine the count of particulates. The number of sample locations must be determined based on the floor area according to ISO standard 14644-1 (Annex B – Point no. B.4 – Sampling) and the area classification.

xi.5 Limits are as defined in table, Airborne Particulate Classification (under point no.

6.3.5 in this report)

xii. Clean room viable particulate count test

xii.1 The viable particulate test shall be performed to monitor the viable particulates, which may be present in critical and controlled areas, and to determine the microbial quality of the air being supplied to each room or area.

xii.2 Viable particulate samples must be taken in each room in normal operating conditions (machinery in use and normal complement of operators present).

xii.3 Sampling must be performed for duration sufficient to sample each room during normal production.

xii.4 Each room must be sampled a minimum of once per shift per day, when the room is in production (operational condition).

xii.5 Testing should be performed over a time period of seventy-two (72) hours concurrent with the temperature, relative humidity and differential pressure monitoring testing.

xii.6 In the event of no production in a room, a minimum of one (1) sample shall be taken for each location daily.

xii.7 Each room must have not less than two (2) sample locations.

xii.8 As defined in tablet: Recommended limits for microbiological monitoring of clean areas during operation (under point no. 6.7 in this report).

xiii. Control, Alarms and Interlocks.

xiii.1 Alarms

xiii.1.1. HVAC systems frequently incorporate safety features such as smoke alarms or noxious fume alarms.

xiii.1.2. HVAC systems frequently include alarms for items such as room pressurization, temperature and relative humidity, which could, if out of specification (OOS), potentially have an adverse effect on product quality.

xiii.1.3. Safety system features should be tested in order to ensure personnel and system safety.

xiii.1.4. Critical alarms should be tested for proper operation to ensure that they are functional and will provide warning before any system, product quality, or personnel safety is compromised.

xiii.1.5. HVAC system alarms are listed below:

xiii.1.5.1. Smoke detector operation.

xiii.1.5.2. Plenum pressure alarms xiii.1.5.3. Room door interlocks xiii.1.5.4. Filter ∆P alarms.

xiii.1.5.5. Room pressure/∆P alarms xiii.1.5.6. Temperature alarms xiii.1.5.7. Humidity alarms.

xiii.2 Interlocking:

xiii.2.1. Interlocks may be mechanical or part of the electrical/mechanical control system.

xiii.2.2. Some interlocks are not associated with loops and may serve to either act as preventive measures (turn the pump off before the tank is empty preventing pump cavitation) or to initiate an activity (an exhaust fan automatically starts when the supply fan is started).

xiii.2.3. Interlock testing may be performed as part of normal sequence of operation testing or as a separate activity.

xiii.2.4. Like sequence testing, interlock testing involves the forcing either through simulation or through ‘expected’ operating conditions of inputs and verifying that the interlock action operations as specified.

xiii.2.5. Door interlocking (X door is opened when Y door is closed, similarly, Y door is opened when X door is closed) system creates to keep the area intact and prevent from the contamination.

xiv. Power Fail and Recovery test.

xiv.1 Verification must be performed that control system can maintain the components of the air-handling unit within the specified range after the power failure (within 15minutes).

xiv.2 Testing operation objective for air handling pneumatic, electric or electronic control system during a power fail and recovery cycle.

xiv.3 Testing procedure must be designed as a function of the system tested. Because the power fail and recovery test is a major system test greatly exercised to prevent damage to personnel or equipment.

xiv.4 The test should be designed in accordance with HVAC and controls design engineers. Therefore, the following must be concluded:

xiv.4.1. Proceed to simulate the failure.

xiv.4.2. Bring the system to complete stop.

xiv.4.3. Wait for the required time before restart to prevent mechanical or electrical (overcharge) damage to the system.

xiv.5 After completion of the foregoing three steps, restart the system.

xiv.6 Recording of the time that it takes for the system to reestablish the approved conditions.

xiv.7 Record the monitored environmental parameters (air volume, pressure differential, temperature, humidity).

xiv.8 The data must be compared that had already been acceptable for the environment tested.

xiv.9 Particular attention must be given to pressure differentials as the best indicator of the system capability to regain control.

xiv.10 Schedule of tests to be performed on regular basis to continuing compliance of system.

Acceptance Criteria Test for Operational Qualification

Test Acceptance Criteria

Verification of Critical

Instrument Calibration All critical instruments must be in the state of calibration.

Operational procedure

compliance test All the operational procedure must comply with Functional Requirement Specification.

HVAC Start-up and

Shutdown Operation Test The air-handling unit start-up and shutdown sequence must operates in accordance with the design specifications and accordance to URS.

Loss of utility test Loss of utility test must not interfere with other ongoing operations.

Airflow Velocities and pattern

The airflow velocity in a unidirectional airflow device should not exceed the limit set in the design criteria. The highest and lowest reading should not be more than 15-20% from the unit average velocity.

HEPA Filter Leak Test 1. Filter media integrity test should pass according to ISO 14644 2. filter seal integrity test should pass according to ISO 14644

Audit of air balance reports/Air volume test

1-The room air change must be not less than 20air changes per hour.

2-Air balance report should include all the data within the pre-determined acceptance criteria

Air pattern test (Air Flow Visualization

1-Air should flow in a parallel stream to prevent the flow of the outside air into the critical environment.

2-Air pattern testing should verify airflows from high-pressure areas (clean) towards lower pressure areas (less clean).

Temperature

Audit/Monitoring (22.0 ± 3.0) °C for all controlled rooms.

Relative humidity

Audit/Monitoring (30 - 65) RH% for all controlled rooms.

Differential air pressure test

1-∆P between any room and the main corridor must be within the tabulated defined range, which ensures that the ∆P between two adjacent rooms, which have same/different classification levels, is not less than 12.5pa. The supply and return air volumes should conform with the range specified. Pressure differential between rooms should be maintained as indicated in the specifications.

2-Absence of cross-contamination (measurement of pressure difference).

Non-viable particulates As defined in table, Airborne Particulate Classification (under point no. 6.3.5 in this report)

Viable Particulates Test As defined in tablet: Recommended limits for microbiological monitoring of clean areas during operation (under point no. 6.7 in this report).

Alarm test and Interlock Test

1-All alarms systems and interlock must comply with Functional Requirement Specification.

2-Door interlocking testing should pass for all doors in sterile area to insure there will be no contamination between each individual area

Power-fail and Recovery

Power-fail and Recovery

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