I.

OBJECTIVE:

To provide an outline for the design of Non-Pen Block Heating Ventilation and Air
Conditioning system AHU-01 to be procured and meets the current Good
Manufacturing practices and other regulatory obligation as per User Requirement
Specification (URS), Technical Requirement Specification (TRS).

II. SCOPE:

The Scope of this document is limited to the qualification of Non-Pen Block, Heating
Ventilation and Air conditioning System (AHU-01) of M/s. Asian Engineering
Company fabricated for M/S IDEAL PHARMACEUTICAL PVT. LTD., Regd.
Office & Factory Bhawaniyapur-14, Nepalgunj, Banke, Nepal.

III. RESPONSIBILITY:

1. M/S IDEAL PHARMACEUTICALS PVT.LTD.

The team consists of one representative from each department Engineering
Service, production and Quality Assurance.
 Collection of Data, User Requirement Specifications (URS) & Technical
Requirement Specification (TRS) for the review of Design Qualification.

2. M/S ASIAN ENGINEERING COMPANY

The engineer should provide the complete technical details of the system
pertaining to its design qualification.

Preparation & Review of DQ Document.

 System Overview.
 System orientation with layout.
 Specification of the sub-components /bought out items, their make, model,
quantity, and backup record/brochures.
 Details of Utilities.
 Material of construction of major components.
 Brief features

 To confirm the safe delivery of the system to the user site.

 To ensure that no un-authorized or unrecorded design modifications
shall take place. If at any point in time , any change is desired in the
mutually design, change control procedure shall be followed and
documented.
  To ensure the proper installation and commissioning of the heating
Ventilation and Air Conditioning system

Iv. SYSTEM DESCRIPTION:

Name of the System: Heating Ventilation and Air conditioning system (Re Circulation)

The system is of Recirculation in the connected area through the ducts. The Heating

Ventilation and Air Conditioning system will suck the 10% fresh air from ambient and the air
passes through 20, 10 Micron filter, CHW coil and the air further drawn by the Blower and
Motor. The air passes through 5- micron filters. The Filtered air passes through the supply air
ducts to 0.3 Micron Hepa filters and then the air enters the individual rooms. The Return air
passes through Return Air 10 Micron Pre filters. The air Sucked by the same blower with the
help of Return air duct.

Location : Non-Pen Block

HVAC Location : Ground Floor

AHU Location : Non-Pen Block Service Floor

Name of the Consult: Asian Engineering Company

Address : Plot. No.574, H.No.9-116/1, Laxmi agar Colony

Boduppal, Hyderabad, Telangana, Pincode-500 092,

India

IV. GENERAL REQUIREMENTS :

 Should have facility for 10 % fresh air from ambient.

 System operation shall be carried out without affecting the potency, content,
purity, and integrity of the intended finished product.
 All above operations shall be carried out in dust- free environment.
 Noise and Illumination should be in specified limits.
 All parts should be easy to access and clean.
  Machine control should be easily visible and accessible.

1.0 ACCEPTANCE CRITERIA:

1.1 The HVAC System Should cover all the basis features and regulatory requirement as
Mentioned in DQ as required for process.
1.2 The Design specification provided by supplier should meet the requirement and
Should be approved by M/S IDEAL PHARMACEUTICALS PVT. LTD.,
1.3 All relevant drawing shall be provided by the suppliers.

2.0 BASIC DESIGN CONCEPT

2.1 HVAC should be designed to meet the following:
 Fine Particulate air filtration,, suitable for the room operation.
 Adequate air changes.
 Cooling sufficient to cater to the all the head sources.
 Humidity levels.
 Partial laminar.
 To maintain pressure gradients and avoid cross contamination.
2.2 The HVAC System should be designed to maintain desired cleanliness levels as

 EU Grade D respective areas

3.0 BREIF WORKING OF THE HVAC SYSTEM
AHU:
To achieve required quantity of air to maintain temperature , room pressure and clean classes.
This unit consists of mixing chamber for return air and fresh air, pre-filter section, cooling
coil section, fan & motor assembly section, fine filter section and HEPA filter section
wherever servicing of the respective sections. This unit shall be made from Double skin puff
insulated panel provided with aluminum hallow sections duly insulted.

COOLING COIL:
To transfer the heat generated from room. This shall be constructed from copper tubes with
Mechanically bonded aluminum fins staggered in the direction of the air flow. The fins
spacing is 12.13/inch .coil header pipes shall be provided with isolating gate valves on the
supply and return lines and a three and a three-way mixing valve on supply line .
BLOWER:

To produce the required quantity of air in the ventilation system / to collect from the room

Through the return air duct and to supply the conditioned air to the room through a supply

Air duct in a re-circulatory air conditioning system. Air volume, static pressure and outlet

Velocity of the fan shall be as per the designed parameters.

MOTOR:

The design, manufacture and performance of induction motor shall comply with all currently

Applicable status, regulations, and safety codes in the locality where the equipment is installed.

All motors shall conform to the latest applicable Indian standards. The relevant Indian Standard

Is IS: 325 Motors Shall be Capable of giving rated output without reduction in expected life span

When Operated continuously under normal supply conditions. Motors shall be suitable for full

Voltage –on-line starting or star-delta starting or any method of starting.

PRE-FILTERS:

Pre-filters shall be Washable HDPE type in GI frame construction and shall be 150mm thick.

The filter shall be 90% efficiency down to 10 microns. The pressure drop through the filter

Shall not exceed 5.0 mm WG while clean.

FINE FILTERS:

Micro vee filters in A1. Construction having an efficiency of 95% down to 5 microns having

a non-woven polyester media housed in necessary soldered plenum.

HEPA FILTERS:

HEPA filter in an aluminum construction having efficiency as specified in the individual air flow
diagram, down to 0.3 microns (test at the factory as per USFED 209E), having a filter media of
sub micro glass fiber filter paper in anodized aluminum construction. HEPA filter shall be
housed in AHU Discharge Box. These boxes will be equipped with pressure cleats, mounting
bolts, filter tightening bolts and perforated diffusion screen. The perforated diffusion screen Will
Have 63% open area and Perforation of size 24x20mm with a pitch of 6mm.All terminal HEPA
filters should be ducted individually to supply air duct. The filters should be provided with PAO
test Port and volume control dampers. All gaps in ceiling should be thoroughly sealed with
pharmaceutical grade RTV caulking and entire ceiling should be tested for leaks. Filter shall be
supplied to site in sealed enclosures with all relevant detail provided on the external surface of
the enclosure. Filter elements shall not be removed from the sealed packing until all the
ductwork is complete, cleaned, pressure tested and decontaminated.

DAMPERS:

In all ductwork the contractor shall furnish and install all dampers where necessary for proper
control of volume and balancing of air distribution system. These dampers shall be separate from
any other dampers provided with supply and return air diffusers, register, and grilles. A multi
leaf opposed blade type damper shall be installed in each supply air duct near the air handling
unit outlet to adjust the total supply air CFM. Dampers shall be of rigid construction, free of all
rattling and vibrations with edges and vibrations with edges crimped or creased for stiffness. All
dampers shall have through rods, not less than 1/2” diameter fastened to blade with two or more
yokes with setscrews. There shall be a steel washer at each end of damper rod.

DUCTING:

All sheet metal ducting work for various air system shall be furnished, installed, completely
connected, tested, and adjusted. The contractor shall make working drawings of all ducts work
and the same shall include details of all fitting, dampers, elbows, grills, return air risers etc.
Required for the proper operation of the air system. Drawings and other details shall be
submitted to the consultants for approval before fabrication. Exact dimensions and locations of
diffusers and grills shall be submitted to the consultant for approval; otherwise, any deviation
after installation shall be rectified without any additional cost. All diffusers, duct lengths, grill
necks/boxes must be kept tightly closed during construction to keep out dust and rubbish. All
sheet metal ductwork shall be fabricated from good quality prime finish galvanized steel sheets.
The zinc coating should be applied uniformly by continuous hot dip method to both sides of the
metal so that the sheet metal can be drawn, lock seamed and spun without danger of flaking or
peering of the zinc coating. The zinc coating would be not less than 120gm/sq. m All duct work
shall be constructed in accordance standards handbook from sheet metal and Air Conditioning
contractor‘s national Association (SMACNA) All Insulated ducts shall be cross-broken . All
ducting shall be built with approved joints and seams and shall be made smooth 0n the inside and
neat on the outside. The duct joints shall be made as airtight as possible. The laps shall be made
in the direction of air flow and no flanges shall project inside the ducting. All elbows shall
preferable be full radius type. Wherever necessary in the duct work suitable access doors and
frames shall be provided to permit inspection, operation and maintenance of dampers, filters or
any other instruments/apparatus concealed behind the sheet metal work.

DUCT INSULATION:

The purpose of insulation is to

a. Minimize temperature rise of air.

b. Prevent sweating of ducts.
c. Prevent ingress of moisture.

No insulation shall be applied to any ductwork or to any surface u