Star Engineering Services

Detailed Engineering
SMR/SOR/SIN nbr.

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Control Narrative and Philosophy

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Dtail Engineering

Moeed Iqbal

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Description

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Approved by

This document is the property of Star Engineering Services and must not be reproduced, stored or disclosed without permission from COMPANY.

Star Engineering Services

Detailed Engineering
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TABLE OF CONTENTS
1.

Objective...........................................................................................................................................4

2.

Reference Documents ......................................................................................................................4

3.

Abbreviations....................................................................................................................................4

4.

Introduction .....................................................................................................................................5

5.

Description of Facility .......................................................................................................................5

6.

5.1.

Overview .......................................................................................................................... 5

5.2.

Description ........................................................................................................................ 5

5.3.

Process Flow Diagram ........................................................................................................ 6

Operation and Control Philosophy ....................................................................................................7

6.1.

Washing ........................................................................................................................... 7

6.2.

Sterilization ....................................................................................................................... 8

6.1.1.
6.1.2.
6.1.3.
6.2.1.
6.2.2.
6.2.3.

6.3.

Description ................................................................................................................................. 8
Procedure................................................................................................................................... 8
Equipments ............................................................................................................................... 8

Service ............................................................................................................................. 8

6.3.1.
6.3.2.
6.3.3.

6.4.

Description ................................................................................................................................. 7
Procedure................................................................................................................................... 7
Equipments ............................................................................................................................... 7

Filling ......................................................................................................................................... 8
Mixing Ingredients .................................................................................................................... 10
Sample Testing ......................................................................................................................... 10

Bottle Packing ................................................................................................................. 11

6.4.1.
6.4.2.

Description ............................................................................................................................... 11
Procedure................................................................................................................................. 11

This document is the property of Star Engineering Services and must not be reproduced, stored or disclosed without permission from COMPANY.

Star Engineering Services

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LIST OF TABLES

Table 1: Reference Documents ................................................................................................................4

Table 2: Cleaning and Washing Equipments ...........................................................................................7
Table 3: Sterilization Equipments.............................................................................................................8
Table 4: Equipments used in Adding- Initial .............................................................................................9
Table 5: Equipments used in Adding - Solid ............................................................................................9
Table 6: Equipments used in Mixing ...................................................................................................... 10
Table 7: Equipments used in Packing .................................................................................................... 11

This document is the property of Star Engineering Services and must not be reproduced, stored or disclosed without permission from COMPANY.

Star Engineering Services

Detailed Engineering
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Control Narrative and Philosophy

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Objective

The main purpose of this document is to provide the control narrative of pharmaceutical batching
process mentioned in the Drawing Apses Auto C-SP-786-01-02.
2.

Reference Documents

Sr. No.
1

3.

Document number
Apses Auto C-S-786-01-02

Abbreviations

PFD
BOM
PSI
RTD
HMI

Title
SP Piping Layout
Table 1: Reference Documents

Process Flow Diagram

Bill of Material
Pounds per Square Inch
Resistance Temperature Detectors
Human Machine Interface

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Star Engineering Services

Detailed Engineering
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Introduction

Star Engineering Services was established in 1994, with a spirit to promote technical skills and to assist
the process industries in all sectors such as:

Pharmaceutical
Food
Textile
Chemical

Star Engineering Services take up the jobs assigned with full assurance, confidence, keeping in view the
time schedule strictly. Work with technique is real sense of Professionalism, Company with its trained
technical staff feel pleasure to accept and under take the challenging critical jobs which can reward a
good reputation in industrial sectors, indeed company pride in mentioning that there has been absolutely
no complaints on the completed projects and Clients, Now they are our life time Clients. Company also
provides Operation and Maintenance services in Electrical , Mechanical and Civil disciplines.
5. Description of Facility
5.1. Overview
The pharmaceutical batch process occurs by mixing of selective inputs at specific temperature and
weight to achieve a desired product.
The inputs that are feeding to the chemical reactor (tank) are as follow:
Distilled water
Nitrogen /Sterilized filter
Raw material or chemical
The outputs that are coming out from the chemical reactor are as follow:
Final product
5.2. Description
The hot distilled water will enter in the vessel (tank) via a distilled water pump and then introduce a
chemical ingredient in the tank and mixed. The product is mixed using an agitator motor. After mixing
introduce the nitrogen in the mixture. After the completion of process the final product will come out
and pass through the chiller to bring the temperature at 11C and then goes for packing.

This document is the property of Star Engineering Services and must not be reproduced, stored or disclosed without permission from COMPANY.

Star Engineering Services

Detailed Engineering
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5.3. Process Flow Diagram

Cleaning
Washing

Sterilization

Service
Filling

Adding Initial Ingredients

Distilled water+ Nitrogen

Adding Solid Ingredients

Mixing

Sample Testing

Packing
Final Product

Figure 1: Process Flow Diagram

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Star Engineering Services

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6. Operation and Control Philosophy

This section should be read in conjunction with the PFDs, BOM. Title description and Document number
for reference documents i.e. PFDs and BOM is mentioned in section-1.2 of this document.
The operational steps of this pharmaceutical bathing process are divided in three major steps. These
steps are as follow:

Cleaning
Sterilization
Service
Packing

6.1. Washing
6.1.1.

Description

The main purpose of cleaning is to wash the vessel after batch complete or usage.
6.1.2.

Procedure

The distilled water is continuously heated at 90oC by heat exchanger. When the operator will give
command of Washing from HMI, the inlet valve will open and start filling the vessel. After the desired
level set point the dead end valve and drain valve will open. The hot distilled water will discharge from
vessel via drain valve. The distilled water temperature in vessel should be 40o C.
The amount of distilled water entered in the vessel is based on time. The time is selected by the
operator. The total amount of distilled water used is monitored and totalized by flow transmitter. After
completion of washing process the dead end valve and drain valve will close.
6.1.3.
Sr No
1
2
3
4

Equipments
Equipment List
Dead End Valve
Inlet Valve
Drain valve
Flow Transmitter
Table 2: Cleaning and Washing Equipments

This document is the property of Star Engineering Services and must not be reproduced, stored or disclosed without permission from COMPANY.

Star Engineering Services

Detailed Engineering
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6.2. Sterilization
6.2.1.

Description

The main purpose of this step is to sterilize the vessel in order to kill the bacteria before the process
starts. The sterilization is done by introducing a pressurized steam and holding a steam at a steam for
specific time.
6.2.2.

Procedure

The operator will press Sterilization button from HMI. The pressure switch will allow the steam to enter
in the vessel if the pressure lies between the required pressure. The steam will be hold in the vessel for
a specific time according to company requirement. The steam is released out from dead end valve and
drain valve. If the vessel is pressurized more than the set pressure then the safety valve will open and
maintain pressure within desired set points.
When the sterilization process will complete then the dead end valve and drain valve will close.
6.2.3.

Equipments

Sr No
1
2
3
4

Equipment List
Dead End Valve
Drain Valve
Safety valve
Vessel

6.3. Service

Table 3: Sterilization Equipments

The service includes the following steps:

Adding Ingredients
Mixing Ingredients
Sample Testing
6.3.1.

Filling

6.3.1.1. Adding Initial Ingredients

Description
The main purpose of this step is to add the initial ingredients according to the batch requirements and
unit specifications.

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Star Engineering Services

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Procedure
The operator will press Add initial ingredients button form HMI. The inlet valve on the distilled water
pipe will open to feed hot distilled water (40O C) the vessel. The inlet valve will open and pump will start
to add distilled water in the vessel for time specific.
After the addition of water the nitrogen will enter in the vessel. The pressure switch will allow nitrogen
to enter if the pressure lies between 19psi to 150psi. The pressure gauge is also used to monitor the
nitrogen pressure. The nitrogen entered for a specific time. The pressure regulator will maintain nitrogen
line pressure according to the process requirements.
Equipments
Sr No
1
2
3
4
5

Equipment List
Pressure Switch
Pressure Regulator
Heat exchanger
Pressure gauge
Vessel
Table 4: Equipments used in Adding- Initial

6.3.1.2. Adding Solid Ingredients

Description
The main purpose of this step is to add the solid ingredients according to the batch requirements and
unit specifications.
Procedure
The operator will press Add solid ingredients button form HMI.
The chemical is added in the vessel according to process requirement and the load cell is used to weight
and monitor the amount of chemical added.
The lid will then be closed after introducing chemical in the vessel.
Equipments
Sr No
1
2

Equipment List
Vessel
Load Cell
Table 5: Equipments used in Adding - Solid

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Star Engineering Services

Detailed Engineering
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Mixing Ingredients

Description
The main purpose of this step is to mix the ingredients according to the batch requirements and unit
specifications.
Procedure
The operator will press Mixing button form HMI. The agitator motor will start to mixing the chemical, hot
distilled water and the Nitrogen. The nitrogen will only enter if the pressure lies between 19 PSI to 150
PSI. The pressure switch and canal filter housing is used in the same line.
The mixing process is time based. The RTD and Level Sensor is used to monitor the mixing process and
for safety of high pressure the safety vent valve.
The safety valve will ensure the pressure of vessel.
Equipments
Sr No
1
2
3
4
5
6

Equipment List
Agitator Motor
Level Sensor
RTD
Safety Valve
Pressure Gauge
Canal Filter Housing
Table 6: Equipments used in Mixing

6.3.3.

Sample Testing

The sample batch testing is done when the process of mixing is complete. If the sample is perfect then
it will proceed to packing otherwise it will mixed again or process personal will take the decision.
The sample is taken at the drain.

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Star Engineering Services

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Control Narrative and Philosophy

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6.4. Bottle Packing

6.4.1.

Description

The packing is done after the batch test is successful and the fluid is forced towards the packing
machine.
6.4.2.

Procedure

The operator will select packing from the HMI. The dead end valve will open and centrifugal pump 2000
Lit\Hr will start. The running feedback of pump will open the pack line valve and chillier line valves. The
final product will flow towards packing line passed through the chillier so that the temperature of
product will drop from 40O C to 11O C.
If the operator will stop the bottle packing line then the pack line valve and chillier line valve will close
and circulation line valve will open. The pump will allow the final product to continuously circulate
between vessel and circulation line.
Equipments
Sr No
1
2
3
4
5
6

Equipment List
Valve
Pressure Gauge
Packing line valve
Chiller line valve
Circulation line valve
Gauge
Table 7: Equipments used in Packing

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