control narrative-rev 1.1

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 page: 1/11

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Rev. Status Rev. date Discipline INS

1.0 22-Dec-15 Doc. Type PRO

CONTRACTOR ref: -- -- -- (Syst.) Unit

ENGINEERING TEAM CONSTRUCTION TEAM PROJECT TEAMSURVEY T EA M

Remarks:

1.0 22-12-15 Dtail Engineering Moeed Iqbal

Rev. Date Description Issued by Reviewed by Approved by

Control Narrative and Philosophy



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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

5.1. Overview .......................................................................................................................... 5

5.2. Description ........................................................................................................................ 5

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

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

6.1. Washing ........................................................................................................................... 7 6.1.1. Description ................................................................................................................................. 7 6.1.2. Procedure................................................................................................................................... 7 6.1.3. Equipments ............................................................................................................................... 7

6.2. Sterilization ....................................................................................................................... 8 6.2.1. Description ................................................................................................................................. 8 6.2.2. Procedure................................................................................................................................... 8 6.2.3. Equipments ............................................................................................................................... 8

6.3. Service ............................................................................................................................. 8 6.3.1. Filling ......................................................................................................................................... 8 6.3.2. Mixing Ingredients .................................................................................................................... 10 6.3.3. Sample Testing ......................................................................................................................... 10

6.4. Bottle Packing ................................................................................................................. 11 6.4.1. Description ............................................................................................................................... 11 6.4.2. Procedure................................................................................................................................. 11



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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



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1. 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. Document number Title

1 Apses Auto C-S-786-01-02 SP Piping Layout

Table 1: Reference Documents 3. Abbreviations PFD Process Flow Diagram

BOM Bill of Material

PSI Pounds per Square Inch

RTD Resistance Temperature Detectors

HMI Human Machine Interface



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4. 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.



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5.3. Process Flow Diagram

Washing

Sterilization

Filling

Sample Testing

Mixing

Adding Initial Ingredients

Distilled water+ Nitrogen

Adding Solid Ingredients

Final Product

Service

Packing

Cleaning

Figure 1: Process Flow Diagram



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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. Equipments

Sr No Equipment List

1 Dead End Valve

2 Inlet Valve

3 Drain valve

4 Flow Transmitter

Table 2: Cleaning and Washing Equipments



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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


1 Dead End Valve

2 Drain Valve

3 Safety valve

4 Vessel

Table 3: Sterilization Equipments 6.3. Service

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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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


1 Pressure Switch

2 Pressure Regulator

3 Heat exchanger

4 Pressure gauge

5 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


1 Vessel

2 Load Cell

Table 5: Equipments used in Adding - Solid



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6.3.2. 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


1 Agitator Motor

2 Level Sensor

3 RTD

4 Safety Valve

5 Pressure Gauge

6 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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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


1 Valve

2 Pressure Gauge

3 Packing line valve

4 Chiller line valve

5 Circulation line valve

6 Gauge

Table 7: Equipments used in Packing