CRITICAL SYSTEMS 704

monograph refers to the compressed air system that is in direct

or indirect contact with the product. The mechanisms for the
removal and control of pollutants and air conditions are carried
out during several stages, continuous and integrated into a
process that must be validated, taking care of each variable
according to the parameters established in its design, which is
based on the risk management of the process and health input
to be manufactured. The main contaminants in compressed air
are classified into total and viable particles, presence of water
vapor, oil, among others; From now on, the minimum
components to be considered will be established in order to
control and comply with the requirements of each of them.

COMPRESSED AIR according to its water content, whether in gaseous or liquid

form.
Below is a table summarizing the permitted water values.
Introduction
Water
Compressed air is another service (system) used in the ISO 8573-1 class
Dew point (°C)
pharmaceutical and health supplies industry, for different 1 ≤-70
purposes, whether for the operation of the pneumatic system of 2 ≤-40
manufacturing equipment, to pressurize chambers or at some 3 ≤-20
stage of the manufacturing process. , the latter being of relevant 4 ≤+3
importance since it influences the assurance of quality and 5 ≤+7
purity of the product. 6 ≤+10
Compressed air is generated from ambient air, which normally 7 Liquid g/m 3
presents a series of contaminants that can represent negative ≤ 0.5
factors for the quality of the products and for the performance 8 0.5 - 5
of the work carried out with it. That is why this system must be 9 5 - 10
designed appropriately for the intended use, since if it is used in x >10
the manufacture of non-sterile products it requires different Total and viable particles
conditions than those required to be met when it is used in the If compressed air has the potential to impact the environment
manufacture of sterile products. The present where it is used, its particle content must meet the same
requirements as the air corresponding to the area classification.
Terms and definitions
Oil
a. Dew point: Temperature at which water vapor begins Below is a table summarizing the permitted oil values.
to condense.
b. Process gases: Gases used in the process that can ISO class Oil or HC
1 ≤ 0,01
affect the quality of the product.
c. Colony forming unit (CFU): Unit by which the number
of culturable microorganisms is expressed.
d. Aerosol: Suspension in a gaseous medium of solid,
liquid or solid and liquid particles that have a negligible
fall or sedimentation speed.
e. Oil: Hydrocarbon mixture consisting primarily of
hydrogen and carbon.
f.Particle: Small discrete mass of solid or liquid material.
g. Viable particle: Any particle that under appropriate
environmental conditions can reproduce.

Types of compressed air

If compressed air comes into direct or indirect contact with the
product, its source of generation, storage and distribution are
considered critical. If this is not the case but it is used in the
operation of the plant, it is only considered a support or service
system.
Depending on the product process and the level of purity
required, the following variables must be controlled.
water content
It is important to note that Compressed Air is classified mainly

COMPRESSED AIR
705 Pharmacopoeia of the United Mexican States 13.0

COMPRESSED AIR.....................................704
Introduction...............................................704
Terms and definitions................................704
Types of compressed air............................704
Total and viable particles..........................704
Oil..............................................................704
ISO class Oil or HC.............................704
General system diagram............................705
Compressors..............................................705
Air treatment equipment............................705
Storage and distribution section................706
Control systems.........................................706
System design............................................706
Compressed Air System Requirements.....706
User requirement.......................................707
Technical requirements.............................707
Regulatory requirements...........................707
Quality risk management...........................707
Qualification..............................................707
Engineering Document Package...............708
System installation and delivery................708
Technical inspection..................................708
Funcionality test........................................708
Installation qualification............................708
Engineering documentation.......................709
GMP related documentation......................709
Verification of components according to technical manuals 709
Operation qualification..............................709
Performance rating....................................709
Maintaining validated state.......................710
must have solid scientific and technological bases that allow the
most appropriate system to be designed according to the
When, as a result of risk management, it is necessary to monitor
identified requirements.
the presence of other contaminants, such as other gases, these
Process compressed air systems comprise two main sections:
must be indicated including the specific concentrations allowed
compressed air generation and storage and distribution.
or determined within the compressed air supply. See ISO 8573.
The generation section includes compressors and air treatment
General system diagram equipment.
The understanding of the process and the product in which Below are some of the most important characteristics of these
compressed air is used, as well as the management of its risks, components:

COMPRESSED AIR
 CRITICAL SYSTEMS 706

Compressors systems. They are generally integrated into the

There are several types of compressors, briefly mentioned compressor package, as well as moisture separators,
below: which remove liquids that come with the air.

• Reciprocating or piston ones. In these devices, the main • Dryers. Once the air leaves the moisture separator, its
compression element is a piston that moves alternately humidity has been significantly reduced, however, it may
inside a cylinder, thus achieving a reduction in the still be saturated. The temperature at which moisture
volume of air to be compressed. Piston compressors can condenses is called the dew point. The dew point can be
measured in the pressurized line or at atmospheric
be simple or double-acting, since one or both sides of the
pressure. Dryers are generally classified according to
piston compress the air. Reciprocating compressors can
dew point. There are different types of air dryers.
be lubricated or non-lubricated; the latter have self-
lubricated poly-tetrafluoroethylene (PTFE) rings. It is • Regenerative dryers with desiccant. These types of
important to emphasize that these types of compressors dryers use porous desiccant substances that adsorb
are only useful when they are guaranteed to be oil-free. moisture and may include silica gel, activated
• The helical ones, oil-free. They are machines where
alumina or molecular meshes. Normally these
teams contain two twin towers. The air to be dried
helical rotors meshed together and located inside a passes through one tower that has the active
casing, compress and move the air towards the outlet. desiccant, while in the other tower the used
These work thanks to a pair of helical type rotors, which desiccant is being regenerated using hot
are coupled to two screws. One of the rotors performs a compressed air.
very similar task to that of the piston.
• Those with screw or lubricated vanes. They have a
• Compression heat dryers. These devices have
regenerative desiccants that use heat during
cylindrical protection, where a rotor is placed right in the
center and the blades almost touch the walls of the compression to achieve desiccant regeneration. These
cylinder. The air enters the compressor when the volume teams can have one or two towers.

• between two pallets is maximum; then as the rotor

• Refrigerated dryers. They use a refrigeration system
to cool the air. The cooling effect causes
rotates, the volume decreases due to the eccentricity condensation of water from the compressed air, this
effect. The air is compressed as it is moved to the outlet. moisture is removed and drained by a separator that
Currently, there are oil-free vane compressors with poly- leads to a drain.
tetrafluoroethylene (PTFE), carbon or Bakelite fins.
• Those with non-lubricated screws. They use external
• Filters. Filters placed after the drying system are required
to remove contaminants and meet process and product
timing gears for the rotors. Since the rotors and the
requirements (user requirements). There are different
casing do not have contact, lubricating agents are not
required inside the compression chamber. The supplied types of filters available.
air is oil free. • Particle filters. Generally used to remove dust, pipe
• Those with diaphragm. These are manufactured in a very scale, metal oxides and desiccant particles.
simple way. They have a connecting rod mounted to • Coalescing Filters. They are intended to remove
which a membrane is added, on an engine. A movement aerosols and small liquid droplets.
is generated where the membrane vibrates and the air can
be compressed thanks to certain valves that contain it. An
• Terminal filters. 0.2 mm cartridge filters can be used
as a terminal filter to obtain “sterile” compressed air.
advantage of these is that the air obtained is very pure,
since it is not in contact with the mechanism. These filters are sanitary type and are made up of
hydrophobic membranes as a filter medium, to
• The centrifuges. These devices consist of one or more eliminate the risk of air passing through them.
horizontal wheels and diffusers, where the fluid is Storage and distribution section
decelerated. The principle of operation of these
It is made up of storage, distribution, connection and points of
compressors is as follows: The air to be compressed
use equipment.
enters through the center of a rotating wheel provided
with radial blades (wheel or impeller) which launch the O Air receptors (Lungs). These equipment are used to
air towards the periphery through centrifugal force. minimize pressure changes during demand periods and
Before the air is guided to the center of the next impeller, their peaks. Receivers improve system reliability and
it is passed through a diffuser that transforms kinetic efficiency as they are used to manage pressure variations
energy into pressure. The staged compression ratio is in the distribution section.
determined based on the changes in velocity and density O The distribution section must meet the following
experienced by the air. characteristics:
Air treatment equipment ° It must be a one-way system, to feed each point of
These equipment have the purpose of removing contaminants use.
such as total particles, viable particles, hydrocarbons and water. O Must include high demand points of use. These
Within this group of components we find the following: must be separated or far from the point of initial
• Air coolers and moisture separators. They are heat
generation or distribution of compressed air to
guarantee the supply of the points of use with the
exchangers designed to remove the heat generated by
compression and thus improve the efficiency of the lowest consumption. If necessary, these points of

COMPRESSED AIR
707 Pharmacopoeia of the United Mexican States 13.0

use must have intermediate or special compressed In the design process it is very important not to lose sight of the
air receivers. fact that the purpose of the Compressed Air system is to
O It must have a main distribution ring. Constructed of provide clean air, with the specified and approved flow and
copper, aluminum or stainless steel tubing. It is the pressure to the products or manufacturing processes, while
most robust power system compared to the one-way meeting the requirements of good quality. engineering
practices, applicable industrial standards, company
system, this ring must have sufficient distribution
requirements and fundamentally regulatory requirements and
capacity to feed the different points of use even with
good manufacturing practices.
demand variability, reducing the need to have It is essential to analyze the system facilities and their
intermediate receivers to attenuate this variation. relationship with the process from the point of view of
This ring allows connection to several compressors. preventing contamination that could occur in critical areas of
the process.
• It must have secondary supply pipes for the The design work is developed in several sequential steps, where
different points of use, also built with copper, each of them generates documents that can be considered
aluminum or stainless steel. It must comply with all “deliverables”.
the conditions of good manufacturing and
engineering practices, qualification, documentation, Compressed Air System Requirements
maintenance, calibration of its measuring The concept of requirements corresponds to the points and/or
instruments, air quality monitoring, etc. conditions that must be met to satisfy the specifications and
• It must have non-return valves, also made of requirements that define the quality of the system that is being
designed.
copper, aluminum or stainless steel, so that air used
in pneumatic or non-critical systems does not return The requirements have been divided into three types to identify
or have a backflow, and in this way ensure that it their origin and the aspect of the quality of the system that they
does not return to the main receiver and are pointing out. User requirements, technical requirements and
contaminate it. regulatory requirements.
• The distribution line must be sized according to User requirement
demand. The size of the pipe must be calculated These requirements are based on the type of products that are
according to the number of points of use, the going to be manufactured and the processes that will be used to
estimated expense at each one and taking into obtain them.
account the probable peaks in demand throughout
Of the products, the pharmaceutical form and its specifications
normal work days. The amount obtained must be
multiplied by a safety factor to cover any must be taken into account, especially those related to the
extraordinary demand. aspects of microbiological content, particles, relative humidity
• Piping installation shall allow for regular inspection
and risks of chemical contamination.
Of the process, it is important to point out the stages in which it
and servicing of valves and measuring instruments.
It must be installed in such a way that it allows for is developed, the critical steps in which the product in process
annual leak checks. may undergo undesirable modifications, as well as the degree
of control that must be established to generate products that
Control systems meet their specifications in a safe and consistent manner. .
Control of the operation and performance of these systems is The aspects of production volume, process times, type of
very important, since compliance with the process parameters machinery that will be used, number of people who will
and quality specifications of Compressed Air as a “fluid- participate in the process, the materials that will be used and the
product” falls fundamentally on them. different stages of the process itself must be analyzed by
Different types of control are available, these range from the generating an engineering document with all the information.
simplest, practically manual ones to those based on the
information and references.
application of computerized systems. Control systems must be
In parallel, all necessary precautions must be taken for the care
qualified according to the degree of complexity on which their
technology is based. Control systems are generally linked to and protection of the personnel who will participate in each
automatic or semi-automatic monitoring methods, online or that stage or step of the process.
allow sampling for laboratory testing. All instruments and
devices linked to making measurements on the air generation Technical requirements
process or the physical characteristics during its distribution The technical requirements refer to the ancillary or auxiliary
must be calibrated. services and architectural installations needed by each of the
The variables that are most frequently monitored are: Pressure, major components of the system and its main accessories.
flow, temperature and humidity measured as dew point. Bases and special constructions, support and fastening
mechanisms, location either inside and protected or placed
System design directly on the outside of the building.
In the design of a Compressed Air system for the health
products industry, the concepts and guidelines of good If the equipment or major components require a special type of
manufacturing practices and good engineering practices play a electrical energy, power supply to hydraulic or pneumatic
very important role. The participation of a multidisciplinary systems with their corresponding service specifications and
team of professionals is essential to address the different issues estimated consumption. It is also important to identify the
and approaches required by this type of project.

COMPRESSED AIR
 CRITICAL SYSTEMS 708

location of the control modules, their specifications and The design review must cover the technical requirements:
services necessary for their correct operation.
The space needs and their location are stated in the system's 1. Architectural plans with location of the system.
technical requirements table. This space is given by the 2. Area classification plan.
dimensions of the equipment, its pipes, connections and the 3. Zoning of equipment and/or systems.
spaces necessary for operators or users to operate and maintain 4. Distribution pipe path plan.
them. 5. Identification plan of points of use.
6. Machine room plan.
Regulatory requirements 7. Equipment specifications table plan.
Regulatory requirements are defined by the rules and 8. Plan and electrical diagram.
regulations that must be met, especially when the system is 9. Piping and instrumentation diagrams (DTI).
operating and the process and product manufacturing are being 10. Installation details drawing of the Compressed Air
carried out, that is, issues of good manufacturing practices, system
however they must also be taken into account. the regulations 11. Construction materials certificate.
associated with the construction, installation and management 12. List of instruments and calibration certificates (critical
of the system from the industrial, ecological and personnel instruments).
safety point of view. 13. List of services required by the Compressed Air system.
It will also be important to consider the market in which the 14. Configuration and list of filters with their quality
products will be marketed and the regulations of the region or certificates.
country to which they will be sent. 15. List of equipment and components.
Quality risk management The design review must cover the regulatory requirements:
Since the process compressed air system is a critical system, it
is essential to carry out the complete risk management study to 1. Regulatory framework that must be complied with.
ensure that the necessary provisions are made to prevent quality 2. Technical standards.
or supply failures that put the quality of the product, process 3. Industrial guides.
and the integrity or safety of personnel.
Comply with the requirements of Good Engineering Practices,
Risk management must be carried out, both at a general level,
Good Manufacturing Practices and Quality. The result of this
that is, viewing the system as a complete entity, as well as
qualification is the acceptance of the design as suitable for its
carrying out detailed studies for each generation action and the
intended use and its release to be implemented.
storage and distribution module, taking into account all the
elements that make up the system.
Delivery and start-up of the system (Commissioning) This
stage of the life cycle of Compressed Air systems can be
Qualification
defined as the delivery-reception and start-up of the equipment
It is advisable to ensure that there will be no changes during the
and components, support or auxiliary services and facilities and
construction and installation of the Compressed Air system or
when applies the automation involved, under a planned,
afterwards, when testing and operation begins. This is achieved
documented and managed engineering approach, with the
by carrying out System Qualification.
purpose that the end user receives the Compressed Air system
This work is carried out by reviewing the design from its
and facilities to full satisfaction, functioning correctly in a
Conceptual stage, until it is in its “For construction” issuing
safety environment that meets the design requirements.
state.
established and user expectations. These activities form part of
1. The Design Qualification seeks to cover the following Good Engineering Practice and provide support for a complete
objectives, among others: and satisfactory qualification at a later stage.
Ensure that the design contemplates the support
requirements of the services that the plant infrastructure Engineering Document Package
must provide. All documents generated in the Detail Engineering stage must
Ensure that the design minimizes risk to quality and be available to verify correspondence with the package of
patient safety. deliverable documents that will be received during the
Ensure that the design is robust and has reliable conclusion and delivery of the Compressed Air system by the
performance. manufacturer and installer to the user.
Ensure that construction and operation are feasible and
have taken into account operating costs, the life cycle of The provider must deliver the following documents to the user:
the system and the risks of its operation.
Ensure that the proposed concepts meet the user and
applicable regulatory requirements (system specifications, 1.Architectural and Engineering Plans as built ( As built ).
capacities of each of the system components, list of 2.Installation diagrams as built ( As built) .
components and calibrated measuring instruments, 3. Technical manuals for the system and its components.
operating conditions: temperature, relative humidity, 4. Catalog of concepts.
etc. ., control characteristics, drawing requirements and 5. Technical catalogs.
quality of materials). 6. Technical sheets.

COMPRESSED AIR
709 Pharmacopoeia of the United Mexican States 13.0

7. Specifications. carried out before placing the thermal insulation, if it has

8.Certificates of construction materials and components. one, since in the event of a leak it would not be possible
9.Calibration certificates for measuring instruments. to detect it in its original position.
10.Results of tests, carried out during the construction and 6. Control systems. Functional tests are essential to verify
installation stages of the system (FAT and SAT tests). that the operating variables can be managed through the
11. Boot test results. control system, to establish the parameters under which
12.Proof of training and training of maintenance, engineering the system will operate.
and system user personnel. 7. It is during the delivery-reception and commissioning of
the Compressed Air system that the system supplier trains
and trains future users of the engineering and
System installation and delivery maintenance departments mainly.
In some cases, the system components can be tested at the 8. Trained and trained personnel must be evaluated to
supplier's facilities (FAT) in the presence of user confirm that the transfer of information has been effective
representatives; however, these tests must be repeated at the and is documented.
final facilities where they will operate, to demonstrate correct
operation at their final site. (SAT). Installation qualification
The construction and installation of the components of the The Installation Qualification has been defined as the validation
Compressed Air system, the pipes and other components that stage in which it is demonstrated that the construction and
are in direct contact with the Compressed Air that the system installation of the Compressed Air System has been carried out
will generate, must be handled in the cleanest environments in accordance with the previously established design
possible, given the difficulty of subsequently obtaining the specifications and there is documented evidence that supports
degree of cleanliness necessary for the operation of the system this demonstration. .
and the air-product quality that is required. To develop the installation qualification activities in a
Special care must be taken against potential contamination that systematic and orderly manner, a specific protocol is generated,
could be generated during the installation of pipes, measuring which after having been reviewed and approved will be used as
instruments and other components and accessories of the a basis for issuing the report that includes the results and
system. evidence of carrying out activities. and the opinion.
The handling and transportation of components must be The installation qualification is divided into two main parts, the
documented and have been supervised at all times. Any engineering and GMP documentation package verification part
situation that could involve mistreatment, impact or contact and the physical verification part of the system components.
with corrosion-generating products must be documented and
explained. Engineering documentation
Once the system equipment has been installed and before
starting the operating tests, the adjustment of the fasteners, 1. User, technical and regulatory requirements.
screws, filters, etc. must be verified. 2. Compressed Air System Installation and Operation
Manual
3. Area classification plans.
Technical inspection 4. Location plans of the Compressed Air System ( As
At the end of the installation, a detailed technical inspection is built ).
carried out, following checklists with the purpose of ensuring 5. Pipe route plans as they were built ( As built ).
all the points indicated in the construction and installation 6. Use point plans.
sequence previously generated by the supplier. 7. Pressure gauge location plans.
This inspection is carried out jointly with the supplier and the
8. Piping and instrumentation diagrams (DTI).
user's representative, especially from the engineering and
9. Description of the control system.
maintenance area.
10. Description of the alarm system.
Funcionality test 11. List of critical measuring instruments.

GMP related documentation

1. Once the technical inspection has been completed in a
satisfactory manner, the functional testing stage begins,
1. Calibration certificates for measuring instruments.
which are listed below (explanatory, but not limiting,
2. Filter quality certificates.
list):
3. Compressed Air System Operation PNO.
2. Pressurization to detect leaks.
4. PNO, Compressed Air System Cleaning.
3. Testing of dehumidifiers, verification of the operation of
5. Preventive Maintenance PNO.
mobile components, verification of the temperature in the
6. PNO for the management of Deviations.
systems, verification of the reactivation of chemical
7. Change control PNO.
components. 8. Maintenance program.
4. Air filter tests, pressure verification, check for absence of 9. Calibration program for Compressed Air System
leaks, filter integrity tests. instruments.
5. Pipe network. Pressure tests on the pipe network are 10. Evidence of Training in Good Manufacturing Practices.

COMPRESSED AIR
 CRITICAL SYSTEMS 710

11. Evidence of Training in Compressed Air System compliance with respect to operation and its specifications.
Operation. The following is an illustrative list of the verifications that are
12. Evidence of Training in Compressed Air System carried out as part of the operation qualification activities.
Cleaning.
13. Evidence of Training in Equipment Maintenance. 1. Control System Operation Verification.
14. Compressed Air System Condition Record Log. 2. Compressor check.
15. Evidence of compliance with the maintenance program. 3. Verification of the dehumidification and drying system.
16. List of qualified personnel in the management of the 4. Verification of the air cooling system.
system. 5. Alarm and security verification.
6. Filter integrity test.
Verification of components according to technical manuals 7. Verification of the operation of measuring instruments.
This part of the Compressed Air system installation 8. Verification of the operation of the systems and services
qualification is intended to verify the correct installation and in that feed the Compressed Air system.
accordance with the approved technical documentation of each 9. Start and stop tests.
of the components and accessories of the system. During the 10. General inspection of the operating system.
verification, evidence is generated that will serve as support to
accept the system and continue with the operation qualification
Performance rating
stage or to report deviations or non-compliance with respect to
the design and its specifications. With the technical information Performance Qualification has been defined as the validation
that describes the structure of the Compressed Air System, a stage in which documented evidence is generated that the
checklist is built that includes the description of each of the Compressed Air System performs according to the user's
components and accessories, the points that are verified, the requirements and the approved design, in a consistent manner.
verification method, the numerical values of measurements and In this qualification, tests are run to demonstrate that the system
variables. physical conditions that apply as well as the generates Compressed Air and distributes it in compliance with
specification that must be met. the specifications and acceptance criteria established in the
Each Compressed Air system is different, so this part of the design to satisfy the user, technical and regulatory
protocol has to be developed in a special way in each company requirements.
and in each system that is going to be qualified. To develop the performance rating activities in a systematic and
It is important to mention that both in the installation orderly manner, a specific protocol is generated, which after
qualification and the operation qualification the documentation having been reviewed and approved will be used as a basis for
generated in the delivery and start-up stage of the system issuing the performance rating report that includes the results
(Commissioning) will be very useful. and evidence of the carrying out of activities, as well as the
opinion.
Operation qualification As part of the protocol, results tables are designed where the
Operation qualification has been defined as the validation stage results of the tests carried out, their methodology, necessary
in which the demonstration that the Compressed Air System measurement equipment, special instructions, specifications
operates according to the approved design in a consistent and limits for the different variables that are measured and
manner is documented. reported are documented.
In this qualification, tests are carried out corresponding to the During monitoring and measurement activities, evidence is
operation of the Compressed Air system. These tests are generated that will serve as support to accept the system or to
specific and depend on the type and characteristics of the report deviations or non-compliance with respect to
system and its components, to confirm that they function performance and its specifications.
properly. These tests are aimed at evaluating the quality of the
The main references to establish the acceptance criteria are the Compressed Air and demonstrating the consistency in the
specifications and indications indicated in the system operation of the components and the complete system.
manufacturer's technical manual. The following list corresponds to the tests that are part of the
To develop the operation qualification activities in a systematic performance qualification:
and orderly manner, a specific protocol is generated, which
after having been reviewed and approved will be used as a basis 1. Total particle count.
for issuing the operation qualification report that includes the 2. Viable particle count.
results and evidence of the carrying out of activities, as well as 3. Air pressure.
the opinion. 4. Dew point.
As part of the protocol, checklists are designed detailing the 5. Hydrocarbons (oil).
tests that will be performed, their methodology, necessary 6. Polluting gases, which will be defined based on the
measurement equipment, special instructions, specifications analysis of the purpose and use of Compressed Air, type
and limits for the different variables that are measured and of process and type of product in which Compressed Air
reported. is applied.
During verification activities, evidence is generated that will
serve as support to accept the system and continue with the In general, the acceptance criteria for the tests corresponding to
performance qualification stage or to report deviations or non- the performance qualification are found in the specific tables

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711 Pharmacopoeia of the United Mexican States 13.0

for each parameter. The tests must be carried out in triplicate carried out and corrective measures taken to bring the system
and for three consecutive days, obtaining satisfactory results. back to compliance with the specification.
The frequency of the performance rating must be at least every
six months, depending on the corresponding risk analysis Hydrocarbons (oil). Two tests are run, that of total
related to the type of process and product it serves. hydrocarbons and that of volatile hydrocarbons. The total
hydrocarbon test is run using indicator tubes, the volatile
The tests, their specifications and acceptance criteria are hydrocarbon test is run using gas chromatography with a flame
described below. ionization detector.
Total particle counting: consists of evaluating the amount of
Polluting gases. Tests can be run to detect foreign gases
particles > 0.5 and > 5.0 µm present in the Compressed Air and
comparing them with the specifications established according considered pollutants such as CO, COr, SO 2 and NOx. All of
to the classification of the clean areas or zones, where the these can be monitored with gas detector tubes.
points of use are located. . A calibrated particle counter with
direct data recording or printing is used. Measurements must be Maintaining validated state
carried out in triplicate and on three consecutive days. With To be considered reliable, a Compressed Air System must first
satisfactory results. The average must meet the specifications have been correctly designed, built and installed according to
indicated in the table. If individual values are found outside the approved design, delivered and verified in a complete and
these limits, the cause must be investigated and the cause timely manner, have been qualified before starting its use in
found. processes and, above all, have developed the technical,
administrative and documentation infrastructure that allows
Viable particle counting: consists of carrying out maintaining and demonstrating the operation of the system in a
microbiological sampling to evaluate the presence of bacteria
permanent and reliable manner in such a way as to continuously
and fungi in the atmosphere generated by the compressed air
ensure its suitability for the intended use.
system, after its flow and outlet pressure have been attenuated.
Having a maintenance system means that the physical and
Monitoring can be carried out using dynamic sampling
functional conditions of each component of the Compressed Air
equipment, which measures the amount of air to be evaluated or
system are maintained permanently, systematically adhering to
by exposing plates with specific culture media for bacteria and
fungi and rotating sampling devices. organized plans and programs, based on the technical
Exposure plates and culture medium devices from kinetic specifications of all components and accessories. , the system
sampling kits are incubated in trypticasein soy agar at 30 to 35 manufacturer's and installer's manuals, procedures, instructions,
°C for 72 h when used only for bacteria or at 30 to 35 °C for 48 records and the participation of trained and qualified personnel
h when I used it for both bacteria and fungi followed by 20 to to execute all the activities included in said plans and programs.
25 °C for 72 h and the results were reported. The qualification of personnel is a very important factor in the
The data generated is reported directly and the average of each operation and conservation of the compressed air system, so it
sampled point is calculated. is necessary that it be organized under a program of training,
Compliance with the provisions of the ISO 8573 series of training and periodic evaluations of personnel related, directly
standards must be considered in the user requirements. The or indirectly, to this system. This ensures, along with
average must meet the specifications indicated in the table. If continuous supervision, that the system is operated, monitored
individual values are found outside these limits, it must be and maintained only by expert personnel on the subject.
confirmed that they do not correspond to a leak or presence of Having the system controlled and with qualified status,
sources of microbiological contamination; if so, they can be monitoring its operating parameters, performance and use
incorporated into the average calculation. becomes essential. This monitoring depends largely on the data
In the event of the presence of microorganisms outside the generated by the measuring instruments, which must be
limits, special sanitation must be carried out in the calibrated under a strict program. The data generated by the
contaminated area, as well as the points of use, their valves, laboratory tests that measure the performance of the system and
changing the terminal filters and carrying out complementary the data from the users of the process areas, of the areas served
sampling to confirm that the level of contamination has been by the Compressed Air system, are also a fundamental part of
controlled. monitoring.
Elements considered consumables of the system, such as filters,
Air pressure. This test is considered online and continuous
pre-filters, as well as moving parts that deteriorate with
monitoring. The values expressed by the calibrated pressure
continuous use, such as belts and gaskets, have to be replaced
gauges, which are located at different points of the system and
periodically based on the periodic inspection of the system and
its distribution line, are taken. The values are recorded in the
corresponding documents and are verified to comply with the these elements in a manner special.
specified and approved values of the system, according to the When modifications to the design, structure or model of major
user's requirements. components are planned, it is necessary to organize and
document the project through the company's change control
Dew point. To carry out this test, calibrated thermohygrometers system, in such a way that the life cycle of the Compressed Air
are used, monitoring in triplicate on three consecutive days, system begins again.
verifying that the values indicated in the table are met. If these The company's CAPA system must be applied when failures or
criteria are not met, the corresponding investigation must be deviations occur that impact the operation or performance of

COMPRESSED AIR
 CRITICAL SYSTEMS 712

the system. The documentation

COMPRESSED AIR
 713 Pharmacopoeia of the United Mexican States 13.0

Regarding failures or deviations, corrective actions and

prevention plans must be available and complete to provide
support and support for maintaining the validated state of the
system.
The periodic evaluation carried out with internal technical
audits allows for a timely diagnosis of the state of the
technical, operational and administrative structure of the
system, from which the corresponding actions are taken to
preserve the compressed air system.

STERILIZATION