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UTILITY SERVICES AND SERVICE FACILITIES

All utilities that could affect product quality should be qualified and
appropriately monitored and action should be taken when these utility limits are
exceeded.

Utility services include

1. Heating, Ventilation And Air Conditioning
2. Plumbing
3. Drainage systems
4. Gas systems
5. Sanitation
6. Personal Facilities
1. Heating, Ventilating & Air- Conditioning System
HVAC is an acronym that stands for the closely related functions of "Heating, Ventilating,
and Air Conditioning"- the technology of indoor environmental comfort.
Heating
There are different types of standard heating systems. Central heating is often used in cold
climates to heat private houses and public buildings. Such a system contains a boiler, furnace,
or heat pump to heat water, steam, or air, all in a central location such as a furnace room in a
home or a mechanical room in a large building. The system also contains either ductwork, for
forced air systems, or piping to distribute a heated fluid and radiators to transfer this heat to
the air.
Ventilating
It is the process of "changing" or replacing air in any space to control temperature or remove
moisture, odors, smoke, heat, dust and airborne bacteria. Ventilation includes both the
exchange of air to the outside as well as circulation of air within the building. Methods for
ventilating a building may be divided into mechanical/forced and natural types.
Air- conditioning
Air conditioning and refrigeration are provided through the removal of heat. The definition of
cold is the absence of heat and all air conditioning systems work on this basic principle. Heat
can be removed through the process of radiation, convection, and Heat cooling through a
process called the refrigeration cycle. The conduction using mediums such as water, air, ice,
and chemicals referred to as refrigerants.
An air conditioning system, or a standalone air conditioner, provides cooling, ventilation, and
humidity control for all or part of an industry, house or
building
The best HVAC design considers the interrelationship of building systems while addressing
energy consumption, indoor air quality, and environmental benefit .HVAC systems can vary
in design and complexity. Modifications can be added to the basic system to reach the desired
HVAC operation.
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2. Plumbing

 Potable water shall be supplied under continuous positive pressure in a plumbing

system
 The pipes and fittings must be of quality good enough to withstand the pressure and
heat conditions
 Compatibility of the materials of construction with the characteristics of the
waste water must be considered during the design of the facility. For example:
Copper plumbing should not be used in drain line for acidic waste water
because it might fail from corrosion but also may result in waste water
discharge above copper concentration limits.
 The pipes should be colour coded according to the material it carries
Grey Raw water
Orange Distilled Water

Green Cooling water

Insulated Steam
White Air

3. Drainage Systems
They remove effluent from spaces, systems, or process.
 Drains shall be of adequate size and, where, connected directly to
sewer, shall be provided with an air break or other mechanical device to
prevent back-siphonage.
 They should be easy to clean. And they must be cleaned at a proper
interval. They must be well closed and air tight.
 For biological waste, it should be treated in a proper manner before
disposal to not to harm the environment.
 Dissolved oxygen content in waste to be disposed in lake or river must
be within limits.
Sanitary waste system
A separate sanitary waste drainage and vent system is provided to convey waste from
toilets, lavatories, non-process service sinks and floor drains. Sanitary drainage is
connected to the site sanitary sewer system generally without treatment. Any other
materials or product that may present a hazard or environmental problem in the sewer
system must be conveyed by a separate waste and vent system.
Laboratory waste system
A separate laboratory waste drainage and vent system is often provided in cases where
acids or caustics used in laboratory processes. It must be sampled and potentially
neutralized before disposal into the sanitary waste system. A batch or continuous
neutralization system may be utilized.
Process Waste System
A separate process waste drainage and vent system is often provided in cases where
products used in the manufacturing process must either be contained separately or
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treated before disposal into the sanitary waste system. If they are contained, they are
usually removed by tanker truck and disposed of offsite.
Because the drainage may be potentially hazardous and certainly possess a potential
contamination and environmental threat, the piping distribution system must either be
protected (double wall piping system) or provided in a location that is easily
monitored (i.e., exposed service corridors).
4. Gas Systems
Many types of gases are utilized in the manufacturing process. The most prevalent of these
include compressed air use in process and controls, breathing air for hazardous environments,
nitrogen, natural gas and propane. All gases used in manufacturing and processing operations,
including the sterilization process, should be sterile filtered at points of use to meet the
requirements of the specific area.
Compressed Air
In general compressed air should be supplied by an “oil-free” type compressor and
must be free of oil and oil vapor unless vented directly to a non-controlled
environment area. It should also be dehumidified to prevent condensation of water
vapor.
Breathing Air
Breathing air is generally provided for use to personnel working in hazardous environments.
It can be provided centrally through a breathing air distribution system or at the local level
with “backpack” type breathing air units worn by each person. Personal units are more
cumbersome but less expensive than central units. Air must be purified to meet OSHA Grade
D ( Occupational Safety and Health Administration) breathing air requirements.
Nitrogen
Nitrogen is an inert gas generally utilized in the pharmaceutical laboratory and manufacturing
environments primarily for the purging of electrical equipment in volatile or explosive
environments. Nitrogen can be provided locally utilizing small individual bottles or
generators. In the central system, nitrogen may be distributed at 100 to 125 psig with pressure
regulation as required. Laboratory nitrogen is generally provided at lower pressures (40 to 90
psig).
Vaccum
Vacuum is utilized throughout pharmaceutical laboratory and manufacturing facilities.
A great deal of vacuum is utilized in the encapsulation and tablet compression areas.
Vacuum is generally generated at between 20 and 25 inches Hg and provided at
between 15 and 20 inches Hg at the inlet.
Natural Gas and Propane
Natural gas and propane are sometimes required in the pharmaceutical laboratory
environment for such processes as maintaining solvent oxidization and heating hot
water and steam.

5. Sanitation in the manufacturing premises

 The manufacturing premises shall be maintained clean and in orderly

manner, free from accumulated waste, dust, debris, etc;
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 Eating, chewing, smoking or any unhygienic practices shall not be

permitted in manufacturing area
 The manufacturing area shall not be used for general thoroughfare for
personnel or storage for storage of materials, except for material
being processed;
 Routine sanitation program shall be drawn up and observed which
shall be properly recorded and which shall indicate:
 Specific areas to be cleaned and cleaning intervals
 Cleaning procedure to be followed, including equipment and
materials to be used for cleaning
 Personnel assigned to and responsible for cleaning operations.
 Records of compliance in respect of sanitation shall be maintained for
inspection.
Objectives of sanitation are
• Removal of dirt and other waste material;
• Minimize the risk of cross contamination between different products in the
same area;
• Reduce the number of micro-organisms in work area;
• Control pests so that these do not affect the quality of materials tp be used
in the manufacture of drugs.
Cleaning Agents and Disinfectants
Cleaning agents help to remove extraneous materials from surfaces some of the
commonly used cleaning agents their chemical nature, concentration in which they are
used and their uses are given below:

Name of Active ingredients Conc. Uses

cleaning agent
Teepol Sodium benzene 0.1 % Multipurpose cleaning
sulphonate, alcohol, agent can be used for
ether sulphate and equipment, floors, glass
alcohol ethoxylate wares

Avipol Liquid detergent of 1% Tanks and vessels in liquid

the sodium alkyl oral manufacturing
sulphate type

Liquid soap Soap As Can be used for washing

required hands, gloves, machine
parts

Vim Mixture of As Toilets, floors, sinks, etc.

detergents required
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Disinfectants destroy pathogenic and other micro organisms and are used to reduce
microbial count in manufacturing area. Commonly used disinfectants their chemical
nature and uses are given here under:

Name of disinfectant Active ingredients Uses

Dettol Chloroxylenol and 2.5 % solution can be
terpineol used for hands and
spray.

Savlon Chlorhexidine 2.5 % solution can be

gluconate and used for treating all
cetrimide surfaces in aseptic area.

Farigenol Dichloro meta xylenol, 2% solution can be

terpineol and soap used for treating all
surfaces in aseptic area.

Formalin Formaldehyde A mixture of potassium

permanganate and formalin
is used for disinfection of
sterile
areas.

6. Personal Facilities
Medical services, canteen facilities, washing and toilet facilities, protective clothing,
change rooms, educational programmes and training, and safety programmes will be
covered in the personal facilities.