Hvac Part3

GMP Updated Training ModulesHeating, Ventilation and Air-Conditioning (HVAC)
Part 3:
HVAC
Objectives
commissioning,
Specifications, requirements
Maintenance instructions and records
HVAC
HVAC
Commissioning
Precursor to qualification
Includes setting up, balancing, adjustment and testing of entire HVAC system to ensure it meets requirements in URS and capacity
Acceptable tolerances for parameters
8.1 Commissioning
8.1.1 Commissioning should include the setting up, balancing, adjustment
and testing of the entire HVAC system, to ensure that it meets all the
requirements, as specifi ed in the user requirement specifi cation (URS), and
capacities as specifi ed by the designer or developer.
8.1.2 The installation records of the system should provide documented
evidence of all measured capacities of the system.
8.1.3 The data should include items such as the design and measurement
fi gures for airfl ows, water fl ows, system pressures and electrical amperages.
These should be contained in the operating and maintenance manuals
(O & M manuals).
8.1.4 Acceptable tolerances for all system parameters should be specifi ed
prior to commencing the physical installation.
8.1.5 Training should be provided to personnel after installation of the
system, and should include operation and maintenance.
HVAC | Slide * of 28 May 2006
HVAC
Installation records – documented evidence of measure capacities of the system
Data: Design and measurement for, e.g. airflow, system pressures
O&M manuals, schematic drawings, protocols, reports
8.1.2, 8.1.3, 8.1.6
World Health Organization
8.1.3 The data should include items such as the design and measurement
fi gures for airfl ows, water fl ows, system pressures and electrical amperages.
These should be contained in the operating and maintenance manuals
(O & M manuals).
8.1.4 Acceptable tolerances for all system parameters should be specifi ed
prior to commencing the physical installation.
8.1.5 Training should be provided to personnel after installation of the
system, and should include operation and maintenance.
8.1.6 O & M manuals, schematic drawings, protocols and reports should
be maintained as reference documents for any future changes and upgrades
to the system.
HVAC
Qualification
Validation is an extensive exercise
Qualification of the HVAC system is one component in the overall approach that covers premises, systems/utilities, equipment, processes, etc.
See also full guidelines on "Validation" in WHO TRS No 937, 2005, Annex 4.
Risk-based approach for HVAC qualification
8.2.1
8.2 Qualifi cation
8.2.1 Validation is a many-faceted and extensive activity and is beyond
the scope of these guidelines. Qualifi cation and validation guidelines are
included in: Expert Committee on Specifi cations for Pharmaceutical Preparations.
Fortieth report. Geneva, World Health Organization, 2005 (WHO
Technical Report Series, No. 937), Annex 4 (see also Fig. 28).
HVAC
Described in a Validation Master Plan (VMP)
VMP to include the nature and extent of tests, and protocols
DQ, IQ, OQ, and PQ
Risk analysis to determine critical and non-critical parameters, components, subsystems and controls
8.2.2 - 8.2.5
8.2.2 The qualifi cation of the HVAC system should be described in a validation
master plan (VMP).
8.2.3 It should defi ne the nature and extent of testing and the test procedures
and protocols to be followed.
8.2.4 Stages of the qualifi cation of the HVAC system should include DQ,
IQ, OQ and PQ.
8.2.5 Critical and non-critical parameters should be determined by means
of a risk analysis for all HVAC installation components, subsystems and
controls.
HVAC
Non-critical systems and components are subjected to Good Engineering Practices (GEP)
Acceptance criteria and limits defined in design stage
Design conditions, normal operating ranges, operating ranges, alert and action limits
8.2.5 - 8.2.11
8.2.5 Critical and non-critical parameters should be determined by means
of a risk analysis for all HVAC installation components, subsystems and
controls.
8.2.6 Any parameter that may affect the quality of the pharmaceutical
product, or a direct impact component, should be considered a critical
parameter.
8.2.7 All critical parameters should be included in the qualifi cation process.
Note: A realistic approach to differentiating between critical and noncritical
parameters is required, to avoid making the validation process
unnecessarily complex.
Example:
• The humidity of the room where the product is exposed should be considered
a critical parameter when a humidity-sensitive product is being
manufactured. The humidity sensors and the humidity monitoring system
should, therefore, be qualifi ed. The heat transfer system, chemical drier or
steam humidifi er, which is producing the humidity controlled air, is further
removed from the product and may not require operational qualifi cation.
Figure 28
Qualifi cation is a part of validation
Equip 1 Equip 2 Equip 3 Equip 4 Equip 5 Equip 6
QUALIFICATION
VALIDATION
System operating ranges
• A room cleanliness classifi cation is a critical parameter and, therefore,
the room air change rates and HEPA fi lters should be critical parameters
and require qualifi cation. Items such as the fan generating the airfl ow
and the primary and secondary fi lters are non-critical parameters, and
may not require operational qualifi cation.
8.2.8 Non-critical systems and components should be subject to GEP and
may not necessarily require qualifi cation.
8.2.9 A change control procedure should be followed when changes are
planned to the direct impact HVAC system, its components and controls
that may affect critical parameters.
8.2.10 Acceptance criteria and limits should be defi ned during the design
stage.
8.2.11 The manufacturer should defi ne design conditions, normal operating
ranges, operating ranges, and alert and action limits.
HVAC
Design conditions and normal operating ranges set to achievable limits
OOS results recorded
HVAC
(e.g. components, type of air treatment needed, materials of construction)
IQ – Verify installation
includes calibration where relevant
HVAC
Qualification (4)
Typical parameters to be included in qualification (based on risk assessment):
Temperature
Room air change rates
Room pressures (pressure differentials)
8.2.17 For a pharmaceutical facility, based on a risk assessment, some of
the typical HVAC system parameters that should be qualifi ed may include:
— temperature
— room air change rates
— room pressures (pressure differentials)
— room airfl ow patterns
— unidirectional fl ow velocities
— room particle counts
— room clean-up rates
— operation of de-dusting
HVAC
Qualification (5)
Typical parameters to be included in qualification (based on risk assessment) (2):
Room clean-up rate
HEPA filter penetration tests
HVAC
Time intervals and procedure to be defined by the manufacturer
Influenced by the type of facility and level of protection
See also ISO 14644 for methods of testing
Requalification, and change control
8.2.18 – 8.2.20, 8.2.9
8.2.18 The maximum time interval between tests should be defi ned by the
manufacturer. The type of facility under test and the product level of protection
should be considered.
Note: Table 3 gives intervals for reference purposes only. The actual test periods
may be more frequent or less frequent, depending on the product and process.
8.2.19 Periodic requalifi cation of parameters should be done at regular
intervals, e.g. annually.
8.2.20 Requalifi cation should also be done when any change, which could
affect system performance, takes place.
HVAC
Tests performed according to protocols and procedures for the tests
Results recorded and presented in report (source data kept)
Traceability, e.g. devices and standards used, calibration records; and conditions specified
HVAC
*Test procedure as per ISO 14644
8. Table 3
Particle count test
Particle counter. Readings and positions
Air pressure difference
Absence of cross-contamination
Airflow velocity
12 months
Velocity measurement
HVAC
8. Table 3
Filter leakage
Containment leakage
Recovery (time)
Airflow visualization
Cleanroom monitoring program (1)
Additional monitoring and triggers, e.g.
1. Shutdown
HVAC
Cleanroom monitoring programme (2)
Particles and Microbiological contaminants
Sufficient time for exposure, and suitable sample size
Identification and marking of sampling points
Definition of transport, storage, and incubation conditions
Results to reflect the procedure/protocol followed
Define alert and action limits as a function of cleanliness zone/class
HVAC
air
Cleanroom monitoring program (3)
HVAC
Definition of Conditions
Qualification – examples of aspects to consider in qualification (OQ, PQ)
HVAC
Test
3 = Operational (ideally used to perform PQ)
This slide shows a series of tests to be carried out during qualification.
There are different tests for the turbulent and for the uni-directional air flows.
The differential pressure on filters is an indication of the clogging of the filters: with the charging of dust on the filters, the differential pressure will increase.
In order to keep the volume of air constant, the fan speed may increase, with the following consequences:
Damage to filters, and passage of unfiltered air
Particles and micro-organismes will be “pushed” through the filter units.
(Inspectors should check whether pressure differential manometers are installed on the AHUs. Without this means of monitoring the filters, the system could go out of control causing contamination problems.)
Airflow patterns are interesting to visualize (smoke tests), as zones without proper flushing can be easily identified.
It is also important to monitor air flow velocities for each HEPA filter according to a program of established intervals because significant reductions in velocity can increase the possibility of contamination, and changes in velocity can affect the laminarity of the airflow.
Airflow patterns should be tested for turbulence, as these can interfere with the flushing action of the air.
Qualification – examples of aspects to consider in qualification (OQ, PQ)
HVAC
Test
3 = Operational (ideally used to perform PQ)
The recovery time (clean-up time) is also an important parameter to be determined. Once doors have been opened and people have been entering a room, the original conditions have been disturbed and, for a short while, before recovering, the room does not always correspond to the laid down parameters.
It is important to know how long this period is. There are no regulations laid down as to how long this clean-up time should be. However, the generally accepted time to clean-up from one cleanroom classification to the next higher classification, should be less than 15 minutes.
It should also be remembered that a room is to be qualified “in operation” when it has a certain number of people in it. After qualification, the number of people in that room, as challenged during qualification, cannot be exceeded.
Temperature and humidity can also be important (comfort in clean areas, stability of effervescent products, etc.)
HVAC
Maintenance
e.g. cleaning of filters, calibration of devices
Appropriate training for personnel
Impact of maintenance on:
8.3.1 There should be a planned preventive maintenance programme,
procedures and records for the HVAC system. Records should be kept.
8.3.2 Maintenance personnel should receive appropriate training.
82
8.3.3 HEPA fi lters should be changed either by a specialist or a trained
person.
8.3.4 Any maintenance activity should be assessed critically to determine
any impact on product quality including possible contamination.
8.3.5 Maintenance activities should normally be scheduled to take place
outside production hours, and any system stoppage should be assessed with
a view to the possible need for requalifi cation of an area as a result of an
interruption of the service.
Verification of design documentation, including
description of installation and functions
specification of the requirements
On site verification (walking around the site)
Inspecting the air-handling system
Air-handling systems:
Should be designed properly, by professionals
Should be treated as a critical system
Conclusion
HVAC
This series of explanations will now be followed by:
Group discussion, with a simple exercise
Short test
Further proceedings
Group Session
The diagram, which is given in handout 3-3-26, shows a layout of a small pharmaceutical plant for non-sterile tablets, liquids and soft-gel capsules, as well as aseptically filled eye-drops.
The group session participants should indicate on the diagram the required cleanroom classes, room pressures (in Pa), as well as any architectural changes which they think necessary.
(This layout is not ideal, but as many different types of operations have been incorporated in the facility as possible, so that different concepts can be addressed.)
(Note to trainer: The next handout, 3-3-27, giving suggested modifications, should not be distributed until after the group discussion has taken place.)
Group Session – modified layout
MAL = Material Air Lock
PAL = Personnel Air Lock
This slide indicates the proposed additions, and can be displayed after the group session discussions have taken place. See handout 3-3-27.
ACTION LIMIT
Normal Operating Range
Packing
Emergency
Exit
Service Corridor

Hvac Part3

Documents

Transcript of Hvac Part3