BASIS OF DESIGN FOR HVAC SYSTEM (GERMAN PHARMA INDUSTRY)

HVAC INTRODUCTION

The objective of this section is to describe the Detailed Engineering of the HVAC System:

➢ ( CLASS – B.C ) Sterile Manufacturing Areas with associated rooms, Corridor Serving by AHU-
9.10.11,12

➢ ( CLASS – D) Dispensing, sampling, Liquid, Cream, Tablet & Capsule , Micro, with associated
rooms, Corridor Serving by AHU-6.7,8,13,14,15

➢ ( CLASS -CNC ) Stores, Packaging area ,Main Change rooms, R&D, with associated rooms, Corridor
Serving by AHU1,2,3,4,5,16

➢ ( CLASS -NC ) Management offices etc Serving by Chilled Water Fan Coil Units

SCOPE

The scope of this section is to define the Heating Ventilation and Air Conditioning (HVAC) system for
the facility.

BASIS OF DESIGN

For the calculation and the HVAC system design, we have taken into account the design and layouts
that meets the requirements of EUGMP guidelines of a typical Pharmaceutical Plant. We made
different assumptions (detailed throughout this document) based on the experience gained in this
type of facility.

Internal and External Conditions

External Conditions

Summer Cooling Dry Bulb Temperature (DB) 48 °C

Wet Bulb Temperature (WB) 17.0 °C

Winter DB 5.0°C

Internal Conditions

Class : B.C,D Rooms

DB : 20 – 25°C

Relative Humidity % (RH) : 30–60 %

Clean Not Classified (CNC) Rooms

DB : 22 – 25°C

RH : 30–60 %

Not Classified (NC) Rooms

DB : 22 – 26°C Summer

Air Changes (per hour: ACH)

➢ Grade B Rooms shall have a minimum of 55 ACH.

➢ Grade C Rooms shall have a minimum of 35 ACH.

➢ Grade D Rooms shall have a minimum of 15 ACH.

➢ ACH for CNC and NC Rooms shall depend on the room requirements and load.

Fresh Air

The building fresh air needs are supplied by means of Sand Trap Louvers with G4 Filter at AHU Area

HVAC SYSTEM

General Purpose

➢ Guarantees zone pressurization as per EU-GMP cleanroom classifications to prevent cross

contamination.

➢ Provides the required ACH rates.

➢ Provides the building fresh air needs.

➢ Dissipate the cooling and heating loads.

➢ Controls the temperature and the relative humidity.

➢ Provides the required air quality by means of filtration.

Description

General

The air conditioning systems is an all-air single duct system.

Air Handling Units are equipped with Chilled Water cooling coils and Hot Water heating coils These
AHUs supply the rooms with the calculated airflow at the required conditions to overcome the
cooling/heating demand and to establish the required ACH rates as per the room classification.

Each area of the plant that requires specific environmental conditions, and that is subjected to
continuous variations of the sensible heat load (which is due to operation of the production
equipment) will have its dedicated AHU:

➢ ( CLASS – B.C ) Sterile Manufacturing Areas with associated rooms, Corridor Serving by AHU-
9.10.11,12

➢ ( CLASS – D) Dispensing, sampling, Liquid, Cream, Tablet & Capsule , Micro, with associated
rooms, Corridor Serving by AHU-6.7,8,13,14,15

➢ ( CLASS -CNC ) Stores, Packaging area ,Main Change rooms, R&D, with associated rooms, Corridor
Serving by AHU1,2,3,4,5,16

➢ ( CLASS -NC ) Management offices etc Serving by Chilled Water Fan Coil Units

Airlocks

are designed for a pressure of 10Pa. All the supplied airflow is considered to exit the room as leakage
through door gaps.

High Efficiency Particulate Air Filters

All air inlets in classified rooms are equipped with Terminal (HEPA) Filters class H13& H14.

Fire dampers

Fire dampers in the ductwork are foreseen in the detailed design drawings in accordance with the
fire protection and its local regulations,
Load Calculations

Room Cooling and Heating Load Components

In order to calculate the rooms cooling and heating loads, we have taken into account the following
factors as industry practices dictate for summer and winter:

➢ Internal Heat Gain from equipment, luminaries and personnel

➢ Heat exchange through the envelop.

➢ Fresh Air Load.

Airflow

The airflow of each room was calculated based on the air change requirements, on the airflow
needed in summer and on the airflow needed in winter.

Cooling and Heating Load Software All the calculations are done using Carrier HAP 5.1 Hourly
Analysis Program

Lighting Load

➢ Room Lighting heat gain estimated @ 2 Watts/ft²,

Process Equipment Heat Gain

Heat dissipation from process equipment from 1.0 KW to 15.0 KW

Transmission Heat Gain & Loss

➢ U-values for the Roof and External walls are 0.15 BTU/ (HR.SQ. FT Deg. F )

➢ U-value for the Clean Room Wal & Ceiling Panel are 0.28 BTU/ (HR.SQ. FT Deg. F )
Exhaust Air Fans

They are used to extract air from Wash Area, toilets, to avoid bad Oduors and ensure ventilation
inside the dedicated rooms.

this type of Fan Consist of the following components:

➢ Centrifugal Inline, Centrifugal Roof Mounted , Wall Monted Exhaust Fan

Common technical specifications

Technical overview

The units shall be hygienic standard. The unit housings shall be constructed with galvanized steel or
aluminum frames and sheet steel - standard units. The units shall be thermal insulated. The unit fans
shall be equipped with frequency converters.

Equipment Sections (coils, fan, filter, motors) has to be accessible via doors. All accessible sections
have to be visible from the outside via small windows.

Ductwork

The Supply, Return and Exhaust air ductwork system will be constructed (as per SMACNA and/or
ASHRAE requirements) GI Sheet Flanged duct. The ductwork distribution will be installed above the
ceiling as per BOD.

Ductwork Accessories

➢ Volume Control Dampers: The casing and the blade shall be in galvanized sheet steel The volume
control Dampers will be either round or rectangular construction depending on the duct branch.

➢ Supply air diffusers and return air grilles within the ceiling: made of galvanized steel, powder
coated.

➢ Terminal Filter box housing the HEPA filter shall be made of galvanized steel powder coated with
Gel seal, integrity test ports, pressure test ports, suitable for pharmaceutical cleanroom application.

➢ Fire dampers in the ductwork are not foreseen but the detail design planning should take the fire
protection and its local regulations into consideration.

➢ Multi- and single leaf dampers for the balancing and shutting off the system. Casing and blades
shall be made of galvanized sheet steel.
➢ Flexible ductwork connections shall be kept to a minimum, and when unavoidable, constructed in
a way to minimize pressure loss (maximum length 1.20 m).