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3.G.1 Introduction
Pharmaceutical rules and specifications often contain very precise but also generally formulated
requirements of air conditioning technology, such as "temperature, humidity and ventilation of premises
should be adequate". This generally formulated requirement is partially substantiated in the
supplementary guideline of the EU GMP Guide for the manufacture of sterile products as it is in the FDA
GMP Regulations (21 CFR 211.46 (b),
chapter D.1.2).
The following chapters give a practical description of the extensive, and sometimes complex, field of air
conditioning technology in terms of the requirements that result from the pharmaceutical environment in
question.
The term air conditioning technology and its further sub-divisions are described in DIN 1946/Part 1.
Two basic types are distinguished by the terms
1. Room ventilation technology essential task of a ventilation system is to supply the desired room
conditions, such as temperature, humidity and cleanliness.
2. Process air conditioning technology. In contrast, the process air systems must guarantee the
required process parameters.
Both types are found and required in the pharmaceutical manufacturing sites.
Figure 3.G-1 shows the structure of the term "air conditioning technology"(extract from DIN 1946/Part 1)
with reference to deployment in the pharmaceutical manufacturing sites.
1. Belong to the equipment in the pharmaceutical manufacturing sites, e.g. fluid bed spray
granulation, drying processes, coating processes
2. Both types of ventilation systems "with"and "without"ventilation functions, as well as a
combination of both are found in the pharmaceutical manufacturing sites
3. Not represented in the pharmaceutical manufacturing sites
In the air conditioning technology structure, a distinction is made between ventilation systems with and
without ventilation functions. The term ventilation function means that the air in the room is exchanged
with external air. The further sub-structure shows the number of thermodynamic air handling functions
with which the ventilation system is equipped. The thermodynamic air handling functions shown in
Figure 3.G-2 apply for the preparation of the inlet air: heating, cooling, humidifying and dehumidifying.
air Recirculating
Air
conditioners
Partial air
Recirculating
air partial air
conditioners
None or
one
conditioner
Recirculating
facilities
facilities
Classification
of room
ventilation
systems
Ventilation
The terms for classification of ventilation systems do not provide any information on the filtering of the
inlet air.
The next chapters deal exclusively with room ventilation facilities. No detail is given of the engineeringrelated planning of ventilation systems, but instead the focus is placed on the fundamental design,
planning, solution options and implementation in terms of the pharmaceutical requirements.
Operational costs of the different systems, especially the costs for energy consumption: current,
heat, cold (cooling, dehumidification) and humidification
Cleanliness requirements
Flexibility
The exhaust air from the rooms is so highly contaminated with impurities that the safe elimination
of impurities can not be assured by the cleaning/filter phases of the ventilation system.
Flexibility is required, i.e. at any time, a manufacturing site for a different product group with other
requirements can be supplied without a risk of cross-contamination.
Figure 3.G-3 Diagram of a pure external air plant
The concentration of impurities in the exhaust air from the rooms is low enough that the safe
elimination of the impurities is achieved via the cleaning/filter stages of the air technology system.
Direct heat recovery without additional heat exchanger (low investment costs).
No flexibility - i.e. a manufacturing site for a different product group with other requirements cannot
be supplied without a risk of cross-contamination
Figure 3.G-4 Diagram of a central recirculating air/mixed air plant
recirculating air facility is usually fitted with a condenser and a filter stage. Decentralized recirculating
air/mixed air facilities with central external air preparation are used with the following conditions:
Supply of different production areas through a joint external air preparation system
The concentration of impurities in the exhaust air from the rooms is so low that safe elimination of
the impurities is achieved via the cleaning/filter stages of the decentralized recirculating air facility.
Flexibility, i.e. a manufacturing site for another product group with other requirement can be
supplied at any time, if the central external air preparation is carried out with a "pure external air
plant".
Single duct system: temperature regulation takes place either by room or by zone via postheating registers or aftercoolers. The air currents (air volume) are today usually configured or
regulated with volume current regulators. With constant air currents, a very simple setting can be
made via throttles such as flaps and perforated plates (
Figure 3.G-7).
Dual duct system: after the central air preparation facility, the inlet air is split across two
differently tempered air supply ducts. The air in the warm duct is heated to a temperature of 25 to
35 C, while the air in the cold duct is cooled to 15 to 18 C, for example. Before a room or zone,
the two air flows are mixed in a blending box according to the required room temperature and heat
burden, and blown in as inlet air. With the blending boxes, constant air currents (air volume) or
variable volumes can be set (
Figure 3.G-8).
Advantages:
Simple design
Disadvantages:
Disadvantages:
Air delivery
Current
Steam
Current
Coolant
Water
Steam
Heating
Cooling/dehumidifying
Humidifying
3.G.3 Filters
To attain the required air quality and conditions in the premises of a pharmaceutical manufacturing site,
different standard components are used to configure an air technology system.
The required purity of the air in the premises can only be achieved with effective cleaning of the external
air or recirculating air. This requires a suitable, correctly designed filter.
Air filters are components through which particles and gaseous impurities are filtered and separated from
the air. The ambient air is penetrated by substances of different particle sizes and materials. This mixture
of ingredients must be cleaned by suitable filters so that the required cleanliness conditions are complied
with in a manufacturing site.
Separation in the air filters (filter medium) is based on different physical effects (see
Figure 3.G-11).
Diffusion effect: the diffusion effect is a consequence of Brownian molecular movement and is
therefore only effective for very small particles. The molecular movement causes a diffuse
movement of the particle along a virtual streamline. It is separated at the fiber if it remains
sufficiently close to the fiber for a long enough time.
Inertness effect: the inertness effect causes separation at the fibers, if the particle is of a
particular size and thus cannot follow the course of the streamline.
Blocking effect: the blocking effect always occurs, if a particle is on a streamline whose distance
from the fiber during circulation is less than half the particle diameter.
Sieve effect: the sieve effect only occurs for a particle whose diameter is greater than the free
cross-section between the fibers (pore width).
The different filter qualities are split into coarse, fine and suspended matter filters according to the
separation capacity of the different particles. This division is based on standardized testing procedures.
Today, following many intermediate steps, the following are two valid European standards for air filters
DIN EN 1822-1 Suspended matter filter (HEPA and ULPA) are the specifications and testing bases for
all filter manufacturers.
Figure 3.G-12 Structure of the air filter in accordance with DIN 24183 (E) Part 1
EA < 20%
EA 20%
Characteristics
Filter group
Filter class
Coarse (G)
G1
Class limits
Am < 65
G2
5 Am < 80
G3
80 Am < 90
Fine (F)
G4
80 Am
F5
40 Em < 60
F6
60 Em < 80
F7
80 Em < 90
F8
90 Em < 95
F9
95 Em
With all mechanical filters, it must be taken into account that the separation power is not constant, but
changes due to the following factors:
Fluctuating dust content of the external air: due to the season (e.g. pollen in spring) and
environment (e.g. emissions of hazardous substances from neighboring plants), the dust content of
the external air fluctuates.
Velocity at which the air passes through the filter medium: with a reduced volume flow in relation to
the test volume flow, the separation rate tends to increase.
Filter cakes: with the increasing contamination (build-up of a filter cake) of the filter, the separation
rate increases due to the additional filtration through the collected dust.
Air humidity: in hygiene areas, the air filter should be prevented from dropping below the dewpoint,
as bacteria and fungus growth is encouraged near the dewpoint. The relative humidity of the air
flushing through should therefore not exceed a maximum value of 95 %.
The filter media used consist of fiberglass or synthetic-organic fibers, which are then connected thermally
or chemically with binding agents. The following models are generally used (see
Figure 3.G-14):
EN
4/9
Figure 3.G-15
Comparison of DIN
779 and Eurovent
Today, the separation rate or effectiveness of the particle air filters is determined as a percentage in
comparison with "atmospheric dust"or "synthetic dust", without producing a reference to a particle size.
The first investigations and standardization activities aim to determine a fractional separation rate for a
defined particle size for the comparison of the efficiency of a particle air filter.
The diagram (see
Figure 3.G-16) shows a comparison of the separation rate (%) for the different particle sizes by pocket
filters with different filter classes. At present, the fractional separation rate should be calculated according
to the Eurovent draft standard with a particle size of 0.4 m.
Figure 3.G-17 DIN EN 1822 Suspended matter filter (HEPA and ULPA)
Part
Title
Status/Valid
July 1998
July 1998
July 1998
Open
Open
According to the above-mentioned DIN standard, suspended matter filters have the filter classes illustrated
in
Figure 3.G-18 with the associated filtration performances.
Figure 3.G-18 Classification of HEPA and ULPA filters according to their filtration performance in
accordance with DIN EN 1822-1)
Integral value
Filter
class
Separation
rate (%)
Local value
Forward
rate (%)
Separation rate
(%)
Forward
rate (%)
H10
85
15
H11
95
H12
99.5
0.5
H13
99.95
0.05
99.75
0.25
H14
99.995
0.005
99.975
0.025
U 15
99.999 5
0.000 5
99.997 5
0.002 5
U 16
99.999 95
0.000 05
99.999 75
0.000 25
U 17
99.999 995
0.000 005
99. 999 9
0.000 1
To assess the suspended matter filters, a testing procedure was defined in DIN EN 1882 in which the
separation rate is determined in the separation rate minimum. The physical basis is the characteristic
minimum curve, which describes the separation behavior of fiber filters and thus also of suspended matter
filters (see
Figure 3.G-19).
The minimum lies in the transition area between stochastic movement (diffusion) through Brownian
molecular movement and inertness effect as the determining separation mechanisms.
The position of the suspended matter filter's separation rate minimum, both in terms of the percentage
separate rate and also of the particle size with the highest penetration, depends on the velocity of the air
flow through the filter medium. The particle size with the highest penetration for a defined filter medium
flow velocity is called the Most Penetration Particle Size (MPPS = separation rate minimum).
Through the connection between the filter medium flow velocity and separation performance, the
separation performance of a suspended matter filter can be increased by reducing the medium velocity
(see
Figure 3.G-20).
Figure 3.G-20 Two minimum curves of a suspended matter filter
The determination and assignment of the individual suspended matter filters to the filter classes is carried
out in accordance with DIN EN 1822. The suspended matter filters of classes up to H 14 can be tested with
the so-called oil strand test. Starting with filter class U15, a leak detection of the particle count method
must be carried out, although it is advisable to perform the particle count method starting with filter class
H 13.
Leakage test
With the oil strand test a leak is visually detected. The filter element is acted upon by a high concentration
paraffin cloud at the raw air side and a tester check, if identifiable oil strands are present at the pure air
side. Every identified oil strand indicates the position of a leak (
Figure 3.G-21).
Figure 3.G-21 Schematic test structure for carrying out the
leakage test on LF units
The leak detection and separation rate determination using the particle method has the following
advantages:
For the particle method, DIN EN 1822 prescribes the following procedure:
Determination of the Minimum Penetration Particle Size (MPPS) with a defined filter medium flow
velocity on a flat filter medium
Fully scan the finished filter element with specified volume flow using MPPS particles
The test methods described in DIN EN 1822 can be implemented by the filter manufacturers with
corresponding test benches. The tests cannot usually be fully implemented when testing fitted suspended
matter filters.
The test structure shown in
Figure 3.G-21 is possible when using the particle count method for fitted suspended matter filters:
The test aerosol is applied to the suspended matter filter at the raw air side of the filter as follows.
LF unit: the aerosol is applied via the ventilator aspiration or the aspiration channel.
Suspended matter filter air outlet: the aerosol is applied via a connection fitted to the raw air side of
the inlet air duct.
The particle concentration of at least 106/ft3 particles of 0.3 m to be applied on the raw air side exceeds
the count range of the particle counter. Therefore, the aerosol concentration is diluted before the particle
counter by a dilution stage of 1:10 or 1:100. Each individual suspended matter filter is then tested for
leaks by slowly and completely passing over the entire filter surface on the raw air side with the particle
counter's isokinetic sensor.
A leak is defined as follows: a leak is present, if the permissible penetration rate of the suspended matter
filter is exceeded or its permissible separation rate is undershot. A distinction is made between integral
and local leaks.
An integral leak is present, if the ratio of the particle concentration measured over the entire filter at the
inlet and exhaust side is not achieved in accordance with the separation rate or penetration rate
prescribed in the filter class.
A local leak is present, if the ratio of the locally measured particle concentration at the inlet and exhaust
side is not achieved in accordance with the separation rate or penetration rate prescribed in the filter
class.
Designs
The filter media of suspended matter filters have a relatively high pressure differential. In order to
accommodate as many filter surfaces as possible on the limited designed space, the filter medium is
folded (see
The older type of fold is the separator technique. The filter medium is folded lengthwise and widthwise
alternately and a separator of corrugated aluminum is inserted in the resulting chambers, which prevents
the filter medium from coming into contact with itself and thus creating an unusable filter surface. A
disadvantage of the corrugated and sharp-edged aluminum separators is that they can tear the filter
medium and create holes in it. This hazard applies during production, transport, fitting and in current
operation through pulsing air currents.
The further development of the folding technique led to the strand design. The strand design technique
allows the filter medium to fold with narrower spaces than the separator design. Thus, a greater filter
surface can be realized in a suspended matter filter with a strand design of the same dimensions. The
contact points of the spacers on the filter medium are significantly lower with the strand design than with
the separator design
This technique results in the following advantages for suspended matter filters with a strand design:
Compressed air, nitrogen, and carbon dioxide are commonly used in cleanrooms. These, and all other
utilized gases, must be of the requisite purity and after filtration their microbiological quality and particle
content should be at least equal to but preferably superior to the air into which the gas is introduced.
Membrane Filters: membrane filters are capable of generating sterile compressed gases which can be
used in processes involving sterile materials, such as components and equipment. The FDA guideline
recommends "that sterile membrane filters be used for autoclave air lines, lyophilizer vacuum breaks, and
tanks containing sterilized materials. Sterilized holding tanks and any contained liquids should be held
under positive pressure or appropriately sealed to prevent microbial contamination. Safeguards should be
in place to prevent a pressure change that can result in contamination due to back flow of nonsterile air or
liquid".
Any moisture on gas filters may cause blockage and permit the growth of microorganisms. Therefore,
precautions should be taken to assure that these filters are dry. Employing hydrophobic filters and, if
possible, applying heat to the filters averts difficulties with moisture residues. The guideline recommends
that any filters that are used to maintain sterility that can affect product be integrity tested at installation
and periodically during its lifetime. The filters should also be tested after any activities that may
compromise the filter. Any failures during integrity testing must be investigated. Also, filters should be
replaced at scheduled intervals.
High-Efficiency Particulate Air (HEPA) Filters: in order to insure aseptic conditions, the integrity of HEPA
filters (
chapter 3.G.3.2 Suspended matter filter - HEPA-Filter) must be preserved. One way of verifying the
integrity of the filters is to perform leak testing at installation and periodically, such as twice per year in
the aseptic processing room. Leak testing should also be performed, when the air quality is found to be
unacceptable, when renovations have taken place in the area, or an investigation is conducted due to a
media fill or product sterility failure. Filters in dry heat depyrogenation tunnels and ovens should also be
leak tested. The guideline allows for the use of alternate methods for the testing of HEPA filters in the hot
zones of depyrogenation tunnels and ovens. However, a justification for the use of alternate procedures
must be provided.
Typical aerosols used for leak testing include dioctylphthalate (DOP) and poly-alpha-olefin (PAO). Caution
has to be used when choosing alternate aerosols, since some increase the risk of microbial contamination
of the environment. Therefore, it is imperative that these alternate aerosols be tested to determine if they
support microbial growth.
Efficiency testing differs from filter leak testing in that the former is designed to establish the filter rating
while the latter detects leaks from the filter media, frame or seal. The efficiency test is conducted by using
a monodispersed aerosol of 0.3 micron sized particles and measuring downstream. The obtained
measurements are an average over the filter surface. Efficiency tests are not designed to detect filter
leaks. An acceptable filter retains at least 99.97 percent of particulates greater than 0.3 m in diameter.
The leak test is conducted by using a polydispersed aerosol of particles with a light-scattering mean
droplet diameter between 0.3 mm and 1 micron, but which includes a sufficient number of particles at
approximately 0.3 mm. An aerosol composed of known concentration and particle size is introduced
upstream of the filter. The filter is scanned with a probe and the leakage is calculated as a percent of the
upstream challenge. The testing procedure and results obtained should be documented in writing. A result
of 0.01 percent of the upstream challenge is considered as a significant leak and requires either the
replacement of the HEPA filter or, when appropriate, repair. In the event of a repair, its success should be
confirmed by performing a retest of the leak test.
In addition to leak testing, filter performance must also be monitored by measuring other filter attributes,
such as uniformity of velocity across the filter and relative to adjacent filters. HEPA filters should be
replaced when nonuniformity of air velocity across an area of the filter is detected. Nonuniformity of air
velocity across an area of the filter will adversely affect airflow patterns. If this occurs, the HEPA filter
should be replaced. The principles discussed in this section of the guideline are also appropriate for use
with ULPA filters.
3.G.4 Principles for the design and planning of air
conditioning ventilation systems
When planning an air technology system, the principles must be clearly and unambiguously defined. For
the ventilation systems to be designed and planned for a pharmaceutical manufacturing site, the external
conditions of the site (see
Figure 3.G-24), the requirements of the premises (see
Figure 3.G-25), the production factors that influence the room climate (see
Figure 3.G-26) and the layout-dependent requirements (see
Figure 3.G-27) must be known. Only if all conditions and requirements are known, can an optimal
ventilation system be designed and planned. The data should be summarized in a room log, which must be
available to every person involved in the planning. (See
chapter 3.A.6 Room book and layout.)
Figure 3.G-24 External conditions of the site
External conditions of the site
External temperature
Air humidity
Sound limits
Noise technical instructions, day/night limits (compliance with sound limits for
the neighborhood)
Emissions of harmful
substances
Altitude
Important, as the key fields of pumps and ventilators, for example, relate to
the standard conditions.
Cardinal points
Wind directions
Purity
Cleanliness class of the rooms in accordance with the EU GMP Guide, FDA Drug Products Produced
by Aseptic Processing guideline, CFR (FDA), DIN EN ISO 14644-1, VDI 2083.
Special data on the required laminar ranges (cleanliness class A). Define size and position in the
layout.
Pressure conditions
compared with
bordering rooms/areas
With defined pressure conditions, it must be defined how the pressure is built up/relieved over
different resistances (e.g. doors). Doors may have to be locked against each other.
Temperature
Temperature range (e.g. 19-25 C), required temperature value (e.g. 22 C), summer compensation,
tolerance (e.g. 2 ), alarm values, separate values for non-working time
Humidity
Humidity range (e.g. 40- 65 % r.h.), required dehumidification and/or humidification value,
tolerance, alarm values, separate values for non-working time
Monitoring devices
Particle concentrations
Temperatures
Air humidity
Pressure conditions
Noise
Usage-dependent requirements
Manufacturing type
Production times
1, 2, 3 shift operation
Reliability
Sources of harmful
substances that have to be recorded
Dust
Solvent
Disinfectant
EX - protection requirements
Heat sources
Persons
Number/activity
Lighting
Production equipment
Containers, pipes
Sterilization processes
Staff clothing
Layout-dependent requirements/dimensions
Number of rooms
Room height in m or ft
Technology areas
Function areas, premises for the assembly of the air technology systems
General room data (room number, room name, area, height, volume etc.)
Volume of inlet air, exhaust air, overflow air (min./max. values; per room)
The second example shows the determination of the heat load in the room. This diagram is shown at the
end of chapter 3.H-5 (
Figure 3.G-31 to
Figure 3.G-32).
3.G.5 Design criteria for the ventilation of premises
The design of a room ventilation system for supplying the rooms is not specified accurately in the various
GMP specifications and rules. The ventilation systems are to be designed so that adequate ventilation is
achieved.
The actual implementation of the requirements for supplying the rooms with air means dealing with the
following design criteria:
How is the inlet air brought into the room? Inlet air flow pattern
How many filter stages are required and with what quality?
Air filter/stages/air filter quality
How should the exhaust air be aspirated from the room? Exhaust air flow pattern
Figure 3.G-29 lists the basic design features with solution approaches for the design of the room supply.
The data does not relate to the design of air technology equipment.
3.G.5.1 Air technology design of a sterile room with negative
pressure plenum
A sterile room with a negative pressure plenum has the following construction principles (see
Figure 3.G-29).
Above the sterile room, a second room is created, which is connected to the sterile room via recirculating
air ducts. The LF areas (filter fan units) are integrated in the ceiling between the sterile room and plenum.
The filter fan units convey the air in the circuit between the sterile room and the plenum. The air is
aspirated from the sterile room via aspiration points near the floor and conveyed to the plenum. In
addition, the required fresh air is brought into the plenum as inlet air. The recirculating air and the inlet air
are brought into the sterile room as initial air. Further inlet air can be brought in via area B through
suspended matter filter air outlets. The excess air is allowed to flow into bordering areas, e.g. locks,
engineering areas of autoclaves, etc. The overflow openings with constant air volumes are designed as
gratings. Overflow openings can be fitted with adjustable flaps to control the pressure.
The diagram shows the main possibility of how a sterile room can be designed with a negative pressure
plenum. Details about the technical solutions for all listed components can be found.
Figure 3.G-29 Sterile room with negative pressure plenum
Figure 3.G-30 Pressure stages and design of the pressure differential measurement for a sterile area
Figure 3.G-32 Ventilation and air-conditioning design - criteria for GMP-compliant production rooms
to
Figure 3.G-32 Ventilation and air-conditioning design - criteria for GMP-compliant production rooms
For operation, maintenance is an essential factor for preserving safe, fully functional and economic
operation in terms of the required statuses (chapter 4.H Maintenance). FDA's Sterile Drug Products
Produced by Aseptic Processing guideline emphasizes maintenance as an important criterion to insure the
proper functioning of air ventilation systems. In section IV.A, the guideline states, "...even successfully
qualified systems can be compromised by poor operational, maintenance, or personnel practices".
The following are targets for air technology systems with planned and regularly executed maintenance
measures (
Figure 3.G-34):
Guaranteeing and complying with physical parameters, such as temperature, humidity, pressure
differences, etc.
Maintenance
Inspection
Maintenance/Service
Repair
Individual measures/activities
Test
Test
Repair
Measure
Adjust
Replace
Assess
Exchange
Amend
Lubricate
Preserve
Clean
The "Building services engineering maintenance working group of the VDMA (association of German
facility designer)" has issued data sheets, which act as a standard for the execution of maintenance
measures in the field of building services engineering. For all building services engineering areas, there are
data sheets for maintenance (see
Figure 3.G-35).
Figure 3.G-35 Composition of maintenance-related VDMA data sheets for building services engineering
Status/
Valid
24
176
1/90
24
186
9/96
9/96
9/88
9/88
9/88
Part
31
4/86
Part 4 Measuring and control technology equipment and building automation systems
9/88
4/96
5/92
24
196
8/96
24
243
Part 1 Introduction
5/94
5/94
5/94
5/94
5/94
Inspection is the subject of the VDMA 24176 "Inspection of air technology equipment and other technical
equipment in buildings" data sheet. Inspection includes testing and measuring activities, with the
evaluation and assessment of the results being an essential task, which should only be carried out by a
specially trained employee. Exact knowledge of the actual status is an important requirement for planning
maintenance measures.
Servicing includes the actual core task of planned maintenance. It includes all measures to ensure the
required status of the ventilation system and is the subject of the VDMA 24186 "Performance program for
servicing of air technology equipment and other technical equipment in buildings" data sheet. Details of
the various crafts of the technical building equipment are given in parts 0 to 6.
Based on the VDMA data sheets, it is possible to establish the measures to be executed for inspection and
servicing and their documentation. From the extensive collection of activities in these data sheets, the
corresponding performance pattern for the respective system can be compiled both for inspection and for
servicing.
The deadlines and intervals for inspection and servicing are to be established in a maintenance plan (see
Figure 3.G-38). Based on experience, the manufacturer's specifications and the significance of the facility,
periods must be defined in which an inspection or service is to be carried out (see
Figure 3.G-36).
To this end, the permissible tolerance periods within which the inspection or servicing must be carried out
should also be established (see
Figure 3.G-37).
Every maintenance measure must be documented. In general, for every activity on a ventilation system,
an entry should be made in the log book to be stored on-site or in the operating diary of the respective
system.
Documentation of the inspection or servicing activities that have been executed is carried out in the form
of records, which are filled in by the person executing the activity and counter-signed by a checker.
The following tables, records and diagrams show proven practical examples for the following maintenance
activities for air technology systems:
Figure 3.G-36)
Figure 3.G-37)
Maintenance plan (
Figure 3.G-38)
Figure 3.G-39)
Figure 3.G-40)
Figure 3.G-42,
Figure 3.G-43,
Figure 3.G-44)
No servicing
1 x servicing
1 x servicing and
1 x servicing
Components
(only as required)
and 2 x inspections
and no
inspection
and 3 x
inspection
1 x inspection
Offices
Non sterile
manufacturing
Laboratories
Clean rooms
(D, C, A + B)
x
x
Tolerance
monthly
2 weeks
quarterly
1 month
half-yearly
2 months
yearly
3 months
the building
the storey
The following columns are to be filled in as shown, in the rows with the individually described activities:
(the "available yes/no"column can be omitted if the forms only contain the components that are available
on the air technology systems).
Figure 3.G-39 Inspection of air technology equipment and systems in accordance with VDMA 24176
Figure 3.G-40 Servicing of air technology equipment and systems in accordance with VDMA 24176
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enlarge,
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Entry
"Available yes/no"
"Report or comment"
Findings, actual values, conditions that are not OK, executed activities,
servicing activities, etc. are to be described in words here.
Figure 3.G-42)
Figure 3.G-43)
Figure 3.G-44).
Entries in the log book are made on-site in chronological order (date and time) in the intended
forms, by the person executing the activity
The log book entry should be made during or immediately after completion of the activity. However,
under no circumstances should it be signed before completion of the activity in question.
After completion of the activity by the person executing the work, the entries are confirmed through
the legible entry of a name and signature.
The entries in a log book page must be checked for completeness and accuracy and initialed by a
person in charge.
Date/time of activity
Type of activity, event (e.g. visual control, servicing, calibration, repair, malfunction)
Signature or signatures
An entry can be corrected by crossing it out. However, the old entry should still be legible after it
has been crossed out. It is not permissible to cover the entry or delete it with Tipp-Ex or Liquid
Paper. Correction or crossing out of an entry must then be confirmed by the person executing the
task by his signature and adding details of when it occurred.
Summary
The term "air technology" is split into the two terms "ventilation technology" and "process air
technology".
The ventilation system used is essentially determined by the following factors:
Cleanliness requirements
Flexibility
The safe, fully functional and economic operation of a ventilation system requires a maintenance system.