Impact Engineers Protocol: Factory Acceptance Test Ointment Manufacturing plant 0x6 LB \e™ y Blossom Pharmaceuticals (ne: FAT-IE210118-115 w goon”Factory Acceptance Test Client: Blossom Pharmaceuticals. Equipment Ointment Manufacturing Plant 600 KG Contents 1. Objective Ml. Scope... Ill, Responsibilities. Iv, _ Plant Description, V. Technical Specifications of the bought outs.. VI. Material Of Construction / Finish... 43 Vil. Utilities Details... Vill, Safety Parameters IX, Factory Acceptance Test Procedure. 48 X. _ Identification Of Personnel Performing Fat.... XI. Criteria Of Acceptability... Xi. Protocol Authorization... CUENT EQUIPMENT - 0 aING PLANT ~ 600Kay 2019 To Design, Engineer, and Supply the OINTMENT MANUFACTURING VESSEL 690 && and to provide assurance that the Vessel is manufactured as per the QUOTATION 090517/IE993163/R1 and it complies with the scope of supply cape each operation proceeds as per design qualification and tolerances prescribed inthe document provided, are the same with utmost Transparency. THs bh fear ard —vhnemed bo Chen The machine shou) 4 be Inspecked and c\eew dt bor disettleh CENT EQUIPMENT¢ ate: 28 May 2019 nck 1, SCOPE: ie ( =~ The Scope ofthis qualification is limited to Design Qualification OINTMENT MANUFACTURING -Ptant G Supplied to Blossom Pharmaceuticals. This oekign Quaienton is part of a validation activity for the OINTMENT MANUFACTURING Plant 600 KG The equipment shall be liquid using Hom to heat/cool and mix liquid in liquid and soluble solids in CUENT EQUIPMENeptan Hi 8-11 Date: 28" May 2019 RESPONSIBILITIE! RESPONSIBIED =: © Client Responsibility - Blossom Pharmaceutical: eas (i oh 4. Te Check and Approve the Design Qualifications. ” ene 2. To witness the Factory Acceptance Test : 3. To Ensure Readiness of Installation Fat lpefore Dispatch Squinnem o Impact Engineers 1. To design, engineer and provide the complete technical detalls of the equipment pertaining to its design qualification. a 2. Vessel Overview [gna S 3. GA Drawing nore 4 vessel Prientation With Layout 5. Provide Specifications of boughtouts Make, Model & Quantity bens A renher) renee 6. Calibration Of Boughtouts rogneg > 7. Provide Material Construction of all Parts \— 8, if any changes / modification required in design, Change Control Procedure should be followed and documented properly under signature of both Client and Impact Engineers 9, To provide with proper Packaging of the afety parameters. Co Taregm ee proper installation and commissioning of the equipment EQUIPMENT8.1115 Date: 28" May 2019 v. PLANT DESCRIPTION: 4) Manufacturing Vessel Working Capacity 700 Liters Gross Capacity 900 Liters Shell Side Jacket Side Design Temperature Oto 130°C Oto 150°C . © Working Temperature io 110°C Oto 130°C * Design Pressure 1 to 3.0 BAR Oto 4.0 BAR + Working Pressure 7110.25 BAR Oto 35 BAR + Hydro test pressure 4.0 BAR Gs | : ($3525 25) «25mm thick Insulation HT Armaflex shall be provided to protect direct contact with Jacket. «50mm Torispherical flanged type top dish of SS316L, with 4 legs support of SS304 * Roughness value Ras0.8 «Product contact Surface will be SS316L «Non-contact surface will be SS304 + Vessel will be CIP competent + Main Shell thickness én, eres Insulation cladding 2mm15 Date: 28 May 2019 4.4) Anchor Agitator «The manufacturing vessel will be having Top Mounted Anchor Agitator with 10 HP motor with 1440 Rpm. + Gear box is provided to increase the torque and decrease the RPM of the anchor. Final speed of the anchor can be varied from up to 50 RPM with the help of the VED. + Single cartridge mechanical seal provided between anchor and agitator to prevent any leakage. miipanicak scot «Teflon scrappers on the anchor provided with adjustable screws, which helps in scrapping of the viscous material on the inner shell wall. 1.2) Bottom Mounted Homogenizer Homogenizer which helps in particle size reduction and emulsification is mounted on the bottom with 10 Hp motor with max 2600 rpm. Ci bo fo\ Working Temperature Oto 110°C Dio 130°C ° Design Pressure -1 to 3.0 BAR 0 to 4.0 BAR * Working Pressure -1to 2.5 BAR 0 to 3.5 BAR «Hydro test pressure 40 BAR Ge TBAR fe Gv ee Sas «50 mm thick Insulation shall be provided to protect direct contact with Jacket «© Torispherical flanged type top dish of SS316L, with 3 leas support of $8304 = Roughness value Ras0.8 Product contact Surface will be SS316L © Non-contact surface will be SS304 noe = Vessel shall be cuecempetent oe © Main Shell is 4mm, Jacket shell 4mm, Insulation shell 2mm. cueNT EQUIP2.1) Cowl Type Bottom Mounted Agitator o¢cee Angulariy placed on the bottom dish with 5 Hp motor and its max¢(6nmis 1440, Double cartridge mechanical seal is provided to prevent leakage, with the cooling arfangement and solenoid valve which prevents dry run of the seal (Speed can be varied upto 1440 with the help of the VED. Samer Cook Aetei fd — melee CAD 2.2) Jacket Full Length Jacket is provided on the shell and bottom dish, with safety valve, vent, pressure gauge and temperaturegauge = Jrndicokte oN GA ard horr(< onctnlah, Temperature is controlled manually with Pneumatic piston valves maintaining temperature. ~ 2.3) Conical Filter The inline Conical Filter is provided at the bottom outlet of Wax phase vessel. The mesh size is 110/24 2.4) Nozzles Top Dish 1) 350mm Hand Hole & Sight Glass We 2) 80 DIN Light nym? 3) 25 TC Safety Relief Valve a 4) 50 TC Static Spray Ball GRO 5) 25 TC Compound Gauge ae T 6) 25 TC Vent Filter Nog I< Jacket encniah en 1) 25 TC Steam Inlet 2) 25 TC Cooling Water Outlet 3) 26 TC Hot water inlet Bottom Dish 1) 25 TC Bottom Outlet 2) 25 TC Temperature Sensor PT 100 EQUIPMENT1 Date: 28" May 2019 3) Water Phase Vessel Working Capacity 500 Liters Gross Capacity 600 Liters Shell Jacket ~ Design Temperature Oto 130°C O10 150°C + Working Temperature Oe 110°C Dio 130°C ‘* Design Pressure 1 to 3.0 BAR 0 to 4.0 BAR + Working Pressure “11025 BAR 0103.5 BAR + Hydro test pressure ZO BAR TEAR ae a CY Bev © 50mm thick Insulation shall be provided to protect direct contact with Jacket * Torispherical flanged type top dish of SS316L, with 3 legs support of SS304 «Roughness value Ras0.8 «Product contact Surface will be SS316L «Non - contact surface will be SS304 = Vessel shall be CIP gompatent cores’ bee a «Main Shellis 5mm, Jacket shell 4mm, Insulation shell 2mactory Acceptance Test FAT-IE210118-1115 Date: 28™ May 2019 ee 3.1) Paddle Type Bottom Mounted Agitator ie S ‘Angularly placed on the bottom dish with 6 Hp motor and its nena is 1440. Double cartridge mechanical seal is provided to prevent leakage, with the cooling atrangement and solenoid valve which prevents dry run of the seal. Speed can be varied upto 1440 with the help of the VFD 3.2) Jacket Full Length Jacket is provided on the shell and bottom dish, with safety valve, vent, Pressure gauge end temperature gauge Temperature is controlled manually with Pneumatic piston valves maintaining temperature 3.3) Conical Filter The inline Conical Filter is provided at the bottom outlet of Wax phase vessel The mesh size is 110/24 3.4) Nozzles Top Dish 4) 350mm Hand Hole & Sight Glass 2) 80 DIN Light 3) 25 TC Safety Relief Valve oa 4) 50 TC Static Spray Ball Fay um? 5) 25 TC Compound Gauge soe 6) 25 TC Vent Filter an 0 Jacket Bee Jacket a 4) 25TC Steam Inlet 2) 25 TC Cooling Water Outlet {NOU \e 3) 25 TC Hot water inlet setts aera Bottom Dish ye 4) 25 TC Bottom Outlet 2) % th bsp Temperature Sensor PT 1004) LOAD CELL Load Cell is provided at the bottom of the all three Vessels ie. (i) Manufacturing vessel (i) Wax Phase Vessel iil) Water Phase Vessel To calculate the level of the mass inside the respective vessels, Load cell will be provided with the indicator on the control panel and PLC as well. It will help to automatically cut off the Valves when the Ro is as mused re i vor set ROCA aes gene! 5) VACUUM SYSTEM 7/ Water ring type vacuum pump 7.5 HP is used for transfer of the processed material from side vessels into Manufacturing Vessel, and to add any additives from bottom inlet port. Vacuum Supply Will be provided to all three Vessels, locoben ox Ve com 7. a 6) PIPING NECA OS at ‘The whole process and transfer of material with the help of interconnecting pipes i) from wax phase to manufacturing vessel via Conical Filter il) from Water phase to manufacturing vessel via Conical Filter Pneumatic Butterfly Valves for Product Transfer , jee ly pigo- me Pneumatic Piston Valves for Jacket Temp Control Deteshee42 gece ih coy 7) CIP PIPING U / Cleaning Process and Recirculation with Pneumatic Piston Valves and Spray ball }) _Cleaning/Recirculation of Water Phase Vessel from Recirculation Pump ii) Cleaning/Recirculation of Manufacturing Vessel from Recirculation Pump. ii) Gleaning/Recirculation of Wax phase Vessel from Recirculation Pump CUENT EQUIPMEN’ Nr —60att E210118-1115 Date: 28 Ma 8) CONTROL PANEL «VED for Top Agitator ( Manufacturing Vessel ) «VED for bottom Mounted Homogenizer( Manufacturing Vessel ) «VFO for bottom Mounted Agitator ( Wax Phase Vessel ) * VED for bottom Mounted Agitator ( Water Phase Vessel ) + DOL Starter for Lobe Pump Lk GP (83 M of +d) * DOL Starter For Vacuum Pump Gere leer yr + DOL Starter for Hydraulic Pump BoM. ee * DOL Starter for Re-circulation Pump An Alagre Se lie (sing 9) HMI SCREEN PLC diage” tN eV oe ie ralrey aie eee le The HMI shall have the following details Software Logic for Manufacturing Process In respective vessels — ok Soniye - ne Seats Wench maa Spout A oupuly? Pm inure ge ease ae ee 5 Transfer ———— ren! Recirculation time ( Manufacturing Vessel ) Discharge to Storage vessel ( Manufacturing Vessel ) Transfer pump “ON” time for recirculation Transfer pump “ON" time for discharge Vacuum pump “ON”Date: 28” May 2019 v. TECHNICAL SPECIFICATIONS OF THE BOUGHT OUTS: TECHNICAL SPECIFICATIONS OF THEEOe—e—eee 4) Main Manufacturing Vessel 1) Pressure Relief valve - 1 No Manufacturer - Mason Techneeds Size - 25 TC Description - EPDM seals. MOC - SS316L Document - Test Certificate Serial No Position On tank — On the Top the Tank ~ au? ea 2) Pressure Relief valve - 1 No Manufacturer ~ Mascon Technesds Size -25TC Description EPDM seals Moc - $8304 Document - Test Certificate SeialNo- Position On tank — On the Top Side of Jacket 148.1115 Date: 28" May 2019 3) Pressure Transmitter - 1 No Manufacturer - Mascon Techneeds Size- 25 TC i oe Description - EPDM seals vee \er / anv? ler MOC - $s304 Sen ox S wrt cs Document — Test Certificate Genve x f SeralNo- ane Position On tank ~ On the Top of Jacket. 4) Compound Gauge - 1 No Manufacturer ~ Baumer Size - 40 TC Description - -1 to 5 Bar MOC - $316L Document ~ Test Certificate SerialNo- 9 Position On tank — On the Top of the Tank cuENT~_ EQUIPMENT - O1N‘otocal - FAT-IE210118-1115 Date: 28” May 2019 5) Pressure Gauge - 1 No Manufacturer ~ Baumer Size - 25TC Description - 0 to § Bar he x Moc - $8304 Document — Test Certificate serialNo- Position On tank — On the Top of Jacket i 6) Temperature Sensor - 1 No Manufacturer ~ Baumer ack ae One © eae size-%hBsP AS is an Description cigars fers ek Moc - ss3i Document - Test Certificate Serial No - Position - On Bottom of the Tank LENT —2 Ph EQUIPMENT M TURING PLANT ~ 601Factory Acceptance Test Protocol - FAT-1E210118-1115 7) Top Mounted Anchor Motor Manufacturer - Crompton Greaves Size-10hp, Description - 1415 rpm ae Document - Test Certificate nes e ‘Serial No - 9° i Position - On the Top Dish 8) Top Mounted Anchor Gear Box Manufacturer — Bontligioli Size - 10 hp, Description - 30:1 Ratio, SF140 Document ~ Test Certificate SerialNo- Position - On the Top Dish CUIENT ~8L0 EQUIPMENT - OINTMENT MANUFACTURING PLANT ~ 600KG Date: 28™ May 2019Factory Acceptance Test Protacol - FAT-IE210118-1 Date: 28” May 2019 9) Bottom Mounted Homogenizer — Manufacturer — Graves Size-10 HP a o Description - 2880 rpm G ee ae eae Serial Number - Position — Othe Tee, ? 10)Lobe Pump Manufacturer — SR Industries Size-2HP/0.75 KW Quokt Sez Description - 760 rpm MOC -S$S316L perme Aofe pees ee Dooument ~ Test Certificate Serial Number- (2 Position=On the Top Dish How cr pure be gn bee yh? purse Currey ‘i 11)Hydraulic Power Pack and Cylinder — 1 Nos Manufacturer ~ Gouary Hydraulic Size ~ 2 HP / Stroke Length - 700mm Description - 960 RPM Document ~ Test Certificate Serial Number - "esition — On the T CLIENT ~ 8105 EQUIPMENT - CIN ACTURING PLAN42)Dynamic Spray Ball ~ 2 Nos Manufacturer - Lechler Size 40 TC Description ~ Dynamic 360° Rotation MOC - SS 316L Document ~ Test Certificate Serial Number - Position - On the Top Dish 13)Pneumatic Butterfly Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size -50TC Descriotion — Pneumatic actuation 5-7 Bar Pressure Moc - ss 316. Document - Test Certificate Serial Number 7, Position - On bottom Outlet 14)Pneumatic Butterfly Valve - 1 Nos Manufacturer - Mascon Techneeds Size - 50 TC Description - Pneumatic 5-7 Bar Pressure MOC - 8S 316L Document - Test Certificate Serial Number - Position — On bottom Outlet far Product Recirculation cuent EQUIPMENT ctory Acce! 44 Beptocol - FAT-1E210118-1115 Date: 28" May 201915)Pneumatic Butterfly Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size - 50TC Description - Pneumatic 5-7 Bar Pressure MOC - SS 316L Document - Test Certificate Serial No - Position - On bottom Outlet for Drain 46)Pneumatic Butterfly Valve - 1 Nos Manufacturer - Mascon Techneeds Size -50TC Description — Pneumatic 5-7 Bar Pressure Moc - Ss 316L Document - Test Certificate ‘Serial Number - Position - On bottom Outlet for Product Recirculation 417)Pneumatic Butterfly Valve - 1 Nos Manufacturer - Mascon Techneeds sie-50 TC. Description — Pneumatic 5-7 Bar Pressure MOC - SS 316L Document - Test Certificate Serial Number - Position - On bottom Outlet for Product Recirculation CLIENT ~810 QUIPMENT - OIN TURIN Date: 28" May 2019Famen Accent ni - PAT-IE210118-1 Date: 28 May 2019 18)Pneumatic Butterfly Valve - 1 Nos Manufacturer - Mascon Techneeds Size - 25 TC Description - Pneumatic 5-7 Bar Pressure MOC - SS 316L. Document - Test Certificate Serial Number - Position - On bottom Outlet for CIP Recirculation 419)Manual Butterfly Valve - 1 Nos Manufacturer - Mascon Techneeds |) Size -50TC Description - Pneumatic 5-7 Bar Pressure MOC - SS 316L Document - Test Certificate Position - On the Shell for Mid Product. Recirculation Ne ea + he one 20)Pneumatic Piston Valve - 1 Nos Ne on . ‘Manufacturer - Mascon Techneeds & See nov! Sze-25TC Se 5 Description — Pneumatic 5-7 Bar Pressure al ocuMENt — Test Certificate es Serial Number - §) Sysred Position ~ At the top For to spray ball CLIENT ~ BLOSSOM Pr t Al val tobe plots nara gun kone off epeicelte or PADFactory Acceptance Test fot 21)Pneumatic Piston Valve - 1 Nos Manufacturer — Mascon Techneeds Size - 25TC Deseription — Pneumatic 5-7 Bar Pressure MOC - SS 316L Document - Test Certificate Serial Number - Position - Jacket Seam Inlet 22)Pneumatic Piston Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size -25TC Description - Pneumatic 5-7 Bar Pressure Moc - SS 316L Document - Test Certificate Serial Number - Position — Jacket Seam Outlet 23)Pneumatic Piston Valve - 1 Nos Manufacturer - Mascon Techneeds Size - 25 TC Description - Pneumatic 5-7 Bar Pressure MOC ~ 8S 316L Document - Test Certificate Serial Number - Position - Jacket Cooling Water Inlet CLIENT ~ 8LOSSOM PF x EQUIPMENT - OINTHE HiT NANUFACTUR 600K6 Date: 28 May 2019 | | |Factory Acceptance T Date: 28" May 2019 24)Pneumatic Piston Valve - 1 Nos Manufacturer - Mascon Techneeds Size - 25 TC Description - Pneumatic 5-7 Bar Pressure MOC ~ 8S 316L Document - Test Certificate Serial Number - Position - Jacket Cooling Water Outlet | | | | | CLIENT ~ BLOSSOM PH ALS, EQUIPMENT - OINTNF FIT MANUFACTURING PLANT ~ G00KGFactory Acceptan: AT-IE2101 2) WAX PHASE VESSEL 4) Pressure Relief valve - 1 No Manufacturer ~ Mascon Techneeds Size - 25 TC Description — EPDM seals. Moc ~Ss316L Document - Test Certificate Serial No - Position On tank ~ On the Top the Tank. 2) Pressure Relief valve - 1 No Manufacturer ~ Mascon Techneeds Size-25TC Description — EPDM seals. MOC - $S304 Document ~ Test Certificate Serial No - Position On tank ~ On the Top Side of Jacket CLIENT ~ BLOSSOM >} EQUIPMENT " RING PLAN Date: 28 May 2019Factory Acceptance test Protocol - FAT-E210118-1115 3) Pressure Transmitter - 1 No Manufacturer ~ Mascon Techneeds Size - 25 TC Description - EPDM seals MOC ~ SS 316L Document - Test Certificate Serial No - Position On tank — On the Top of Jacket. 4) Compound Gauge - 1 No Manufacturer ~ Baumer Size - 40 TC Description ~~1 to 5 Bar MOC - SS 316L Document — Test Certificate Serial No - Position On tank — On the Top of the Tank cuENT EQUIPMENT ~ OIN Date: 28” May 2019Factory Acceptance TestiProtocol - FAT-IE210118-1115 5) Pressure Gauge - 1 No Manufacturer ~ Baumer Size - 25TC Description - 0 to § Bar MOC - SS 316L Document - Test Certficate Serial No - Position On tank ~ On the Top of Jacket 6) Temperature Sensor - 1 No Manufacturer ~ Baumer. Size —% th BSP Description - PT100 Type MOC - SS316L. Document - Test Cerificate Serial No - Position ~ On Bottom of the Tank CLIENT ~ 8LOSSOM Pi TICALS EQUIPMENT - IFACTURING PLANT ~ 600K6 Date: 28" May 2019Factory Acceptan 118-1115 7) Bottom Mounted Stirrer Manufacturer — Crompton Greaves Size—5 HP Description - 1440 rpm Document - Test Certificate Serial Number - Position — On the Top Dish 8) Dynamic Spray Ball - 1 Nos Manufacturer - Lechler Size-40 TC Description — Dynamic 360° Rotation MOC ~SS 316L Document - Test Certificate Serial Number - Position — On the Top Dish CLIENT ~ 8L0SSO1V EQUIPMENT ~ c LANT ~ 600K6 Date: 28" May 20199) Pneumatic Butterfly Valve - 1 Nos ‘Manufacturer - Mascon Techneeds Size— 50 TC Deseription - Pneumatic actuation 5-7 Bar Pressure MOC - SS 316L Document - Test Certificate Serial Number - Position — On bottom Outlet 10)Pneumatic Butterfly Valve - 1 Nos ‘Manufacturer - Mascon Techneeds Size - 50 TC Description - Pneumatic 5-7 Bar Pressure MOC ~ SS 316L Document - Test Certificate Serial Number - Position - On bottom Outlet for Product Transfer CLIENT ~ SLOSSOM PHARMACE! EQUIPMENT ~ OINTVIEN TURING PLANT — 600KG44)Pneumatic Butterfly Valve - 1 Nos Manufacturer — Mascon Techneeds Size-50 TC Description — Pneumatic 5-7 Bar Pressure Moc - Ss 316L Document — Test Certficate Serial No - Position — Product to Drain 12)Pneumatic Butterfly Valve - 1 Nos Manufacturer — Mascon Techneeds Size-25 TC Description — Pneumatic 5-7 Bar Pressure MOC ~ SS 316L Document - Test Certificate Serial Number - Position — On bottom Outlet for CIP Recirculation 13)Manual Butterfly Valve - 1 Nos Manufacturer — Mascon Techneeds Size-50TC Description — Pneumatic 5-7 Bar Pressure MOC ~ SS 316L Document - Test Certificate Position — On the Shell for Mid Product Recirculation,14)Pneumatic Piston Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size - 25 TC Description — Pneumatic 5-7 Bar Pressure MOC -SS 316L Document - Test Certificate Serial Number - Position — At the top for spray ball 15)Pneumatic Piston Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size-25TC Description — Pneumiatic 5-7 Bar Pressure MOC ~ $S 316L Document - Test Certificate Serial Number - Position - Jacket Seam inlet 16)Pneumatic Piston Valve - 1 Nos Manufacturer — Mascon Techneeds Size-25TC Description — Pneumatic 5-7 Bar Pressure MOC - SS 316L Document - Test Certificate Serial Number - Position - Jacket Seam Outlet Date: 28" May 20191 Date: 2 17)Pneumatic Piston Valve - 1 Nos Manufacturer — Mascon Techneeds Size ~25TC Description ~ Pneumatic 5-7 Bar Pressure MOC - SS 316L Document ~ Test Certificate Serial Number - Position ~ Jacket Cooling Water inlet 18)Pneumatic Piston Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size -257C Description - Pneumatic 5-7 Bar Pressure MOC ~ SS 316L Document - Test Certificate Serial Number - Position — Jacket Cooling Water Outlet CLIENT MENTcceptan; ol FA 3) WATER PHASE VESSEL 1) Pressure Relief valve - 1 No Manufacturer - Mascon Techneeds Size -25 TC Description — EPDM seals, Moc ~ss316L Document - Test Cerificate Serial No - Position On tank — On the Top the Tank 2) Pressure Relief valve - 1 No Manufacturer — Mascon Techneeds Size -25 TC Description - EPDM seals. MOC - $8304 Document - Test Certificate Serial No - Position On tank ~ On the Top Side of Jacket, 210148. Date: 28™ May 2019Factory Acceptance ‘itoco| - FAT-IE210118-1115 Date: 28™ May 2019 3) Pressure Transmitter - 1 No Manufacturer - Mascon Techneeds Size-25 TC Description - EPDM seals MOC ~ SS 316L Document ~ Test Certificate Serial No - Position On tank — On the Top of Jacket. 4) Compound Gauge - 1 No Manufacturer — Baumer Size—40TC Description ~ -1 to § Bar MOC - Ss 316L Document ~ Test Certificate Serial No - Position On tank ~ On the Top of the Tank CLIENT ~ BLOSSOM PI ICAL EQUIPMENT - OINTW TuFactory Acceptance 78:1 Paiytocol - FAT-IE210118-1 5) Pressure Gauge - 1 No Manufacturer ~ Baumer Size -25TC Description - 0 to § Bar MOC ~Ss 316L Document ~ Test Certificate Serial No- Position On tank — On the Top of Jacket 6) Temperature Sensor - 1 No Manufacturer ~ Baumer. Size -% th BSP Description - PT100 Type MOC - SS316L Document — Test Certificate Serial No - Position — On Bottom of the Tank CLIENT ~ BLOSSOM PH FUTICALS, EQUIPMENT ~ OINTH NUFACTURING PLANT ~ 600KG Date: 28” May 2019Factory Acceptance u 10118-111 7) Bottom Mounted Stirrer Manufacturer — Crompton Greaves Size -5 HP Description - 1440 rpm Document ~ Test Certificate Serial Number - Position — On the Top Dish 8) Dynamic Spray Ball — 1 Nos Manufacturer ~ Lechler Size— 40 TC Description ~ Dynamic 360° Rotation MOC - SS 316L. Document - Test Certificate Serial Number - Position - On the Top Dish CLIENT ~ BLOssoM Preys’ JTICALS, EQUIPMENT - OINTM 4 f URING PLANT ~ 600KG Date: 28” May 2019Factory Acceptance'Test Protocol 0118-1115 9) Pneumatic Butterfly Valve - 1 Nos Manufacturer - Mascon Techneeds Size - 50 TC Description - Pneumatic actuation 5-7 Bar Pressure MOC - $8 316L. Document ~ Test Certificate Serial Number - Position — On bottom Outlet 10)Pneumatic Butterfly Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size - 60 TC Description - Pneumatic 5-7 Bar Pressure MOC - $8 316L Document - Test Certificate Serial Number - Position — On bottom Outlet for Product Transfer CLIENT ~ 8105 EQUIPMENT ~ OINTN Date: 28” May 201911)Pneumatic Butterfly Valve - 1 Nos Manufacturer — Mascon Techneeds Size -50TC Description - Pneumatic 5-7 Bar Pressure MOC ~ $8 316L Document - Test Certificate Serial No - Position — Product to Drain 12)Pneumatic Butterfly Valve - 1 Nos Manufacturer — Mascon Techneeds Size-257C Description - Pneumatic 5-7 Bar Pressure MOC ~ Ss 316L Document - Test Certificate Serial Number - Position — On bottom Outlet for CIP Recirculation 13)Manual Butterfly Valve - 1 Nos Manufacturer - Mascon Techneeds Size -50 TC Description ~ Pneumatic 5-7 Bar Pressure MOC ~ Ss 316L Document - Test Certificate Position - On the Shell for Mid Product Recirculation Date 28 May 201914) Pneumatic Piston Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size - 25 TC Description ~ Pneumatic §-7 Bar Pressure MOC - SS 316L Document — Test Certificate Serial Number - Position — At the top for spray ball 15) Pneumatic Piston Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size~25TC Description - Pneumatic 5-7 Bar Pressure MOC ~ SS 316L Document - Test Certificate Serial Number - Position - Vacuum inlet 28 May 20:tory Acceptani tocol - FAT-IE210118-1115 16) Pneumatic Piston Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size - 25 TC Description ~ Pneumatic 5-7 Bar Pressure MOC ~ $8 316L Document ~ Test Certificate Serial Number - Position - Jacket Seam inlet 17) Pneumatic Piston Valve - 1 Nos ‘Manufacturer ~ Mascon Techneeds Size -251C Description — Pneumatic 5-7 Bar Pressure MOC -SS 316L Document - Test Certificate Serial Number - Position — Jacket Seam Outlet CuENT SON 1 EQUIPMENT - © RING PLAN Date: 28™ May 2019actory Acceptance'Tast Protocol -'FAT-IE210118-1115 18) Pneumatic Piston Valve - 1 Nos Manufacturer — Mascon Techneeds Size-25TC Description ~ Pneumatic 5-7 Bar Pressure MOC ~ SS 316L Document — Test Certificate Serial Number - Position ~ Jacket Cooling Water Inlet 19) Pneumatic Piston Valve - 1 Nos Manufacturer — Mascon Techneeds Size-25TC Description — Pneumatic 5-7 Bar Pressure MOC ~ $$ 316L Document ~ Test Certificate Serial Number - Position — Jacket Cooling Watef Outlet CLIENT —BLOSSO L EQUIPMENT Date: 28" May 2019Factor ol - FATHE210118-1115 4) CIP & Re - Circulation 1) Pneumatic Piston Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size -25TC Description - Pneumatic 5-7 Bar Pressure MOC ~$S 316L Document - Test Certificate Serial Number - Position — CIP inlet for Water Phase Vessel 2) Pneumatic Piston Valve - 4 Nos Manufacturer — Mascon Techneeds a Size-25 TC Description — Pneumatic 5-7 Bar Pressure MOC - SS 316L Document — Test Certificate Serial Number - Position - CIP Inlet / Recirculation for Water Phase Vessel 3) Pneumatic Piston Valve - 1 Nos Manufacturer Mascon Techneeds Size -251C Description — Pneumatic 5-7 Bar Pressure MOC - $$ 316L Document - Test Certificate Serial Number - Position - CIP Inlet fof Main Manufacturing Vessel cuent s EQUIPMENT PLAN: Date: 28" May 20194) Pneumatic Piston Valve - 4 Nos Manufacturer - Mascon Techneeds Size~25TC Description — Pneumatic 5-7 Bar Pressure MOC - SS 316L Document — Test Certificate Serial Number - Position — CIP Inlet / Recirculation for Main Manufacturing Vessel 5) Pneumatic Piston Valve - 1 Nos Manufacturer ~ Mascon Techneeds Size -25 TC Description - Pneumatic 5-7 Bar Pressure MOC - SS 316L Document - Test Certificate Serial Number - Position — CIP Inlet for Wax Phase Vessel 6) Pneumatic Piston Valve - 4 Nos Manufacturer ~ Mascon Techneeds Size~25 TC Description - Pneumatic 6-7 Bar Pressure MOC ~ $8 316L Document ~ Test Certificate Serial Number - Position — CIP inlet / Recifculation for Wax Phase Vessel Date: 28 May 2019vi. MATERIAL OF CONSTRUCTION / FINISH SRNO | DESCRIPTION FINISH moc 1. | Vessel Top dish Internal s 0.8 Ra jim SS316L, 2,_ | Vessel Shell Internal = 0.8 Ra pm SS3I6L 3, _| Vessel Bottom dish Internal $0.6 Ra um SS316L 4, | Light & Sight Glass Assembly ee eas 0.8Raym ~ $8 316L 5. _| Pneumatic Butterfly Valve Internal s 0.8 Ra pm SS 316L 6. | Compound Gauge Mirror finish SS316L 7, | Jacket 5 SS 304 3, | Insulation > Glasswool 9. | Cladding External- 2B 35304 40, | Temperature Sensor Mirror finish SS3T6L | 4,, | Gaskets Food Grade SILICON 42, | Support Pipe legs Internal < 1.0 Ra jim $5304 13. T Eectieal Control Panel Maite finish 35.304 ink cuenr EQUIPMEN oe aeactory Accept, £210118-1115 Date: 28" May 2019 vi. UTILITIES DETAILS DESCRIPTION SPECIFICATIONS ] 1.Electrical i | Phase 3 Phase Vottage 415 V Frequency 50 Hz 3. WEI Pressure 2.5 bar Line Size 257C 4. Utility Steam aad pie ie Pressure 3 Bar (g) > Line Size [este U7 a . 5. Drain st Size 7mm = Colitchvt on\? _& 6. CIP Line ee - = -- Travia ‘Sze 2mm ite Pressure —, 3 bar ayein %Compressor~ Bay CorspYOy.¥ by ‘Sue FAOBAR/ 15 CFM | eee PU Tube Size mm Bae be cuent MP EQUIPMENTvil. SAFETY PARAMETERS * Main circuit is provided with MCB of appropriate capacity * Control circuit is provided with MCB of appropriate capacity, + Anchor drive is provided with MCB and electronic overload protection. + HSE drive is provided with MCB and electronic overload protection + Wax Stirrer drive is provided with MCB and electronic overload protection. + Water Stirrer drive is provided with MCB and electronic overload protection, + The Vacuum pump is provided with MCB and OL relay of appropriate capaci. * The Hydraulic power pack motor is provided with MCB of appropriate capacity. * The UP movement of the Top dish will not let the Homogenizer and Anchor to rotate Stew CLIENT ~ BLOS EQUIPMENT ~ OIN NG PLANx. FACTORY ACCEPTANCE TEST PROCEDURE: + Factory Acceptance Test Procedure shall be as follows: + After the completion of erection work of the equipment, Client shall be informed to witness the Factory Acceptance Test (FAT). Client shall witness the FAT at the manufacturer site and record all the data in the prescribed FAT document Hydro Test —— PrOC™ ey RaValue Test. —— General Assembly, P8ID Design Verification, Cheok list Report Pre-instaliation requirements Final report. oy cies) x. IDENTIFICATION OF PERSONNEL PERFORMING FAT FROM BLOSSOM PHARMACEUTICALS {Nam | Name: Name: Designation: Designation: Designation: Date: Date:i FATAE2I0 1 Date: 28" May 20 x CRITERIA OF ACCEPTABILITY: 1) Manufacturing Vessel + PHYSICAL / DIMENSIONAL VERIFICATION GA Drawing Verification: Satisfied 7 Not Satisfied Signature P&ID Drawing Verification, Satisfied / Not Satisfied ——. bee bel + Vessel . Vacuum Test: (Test Pressurey60mmihg) — /\U' Spew Duration 30 Min Hold up Pressure | mmihg Satisfied 7 Not Satisfied e ‘Signature marchisn pec rh copied + Jacket = Hydro Test: (Test Pressurfi3.9ba)) 0 - Duration 30 Min [Hold Up Pressure Bar “47 Satisfied 7 Not Satistied Signature el piar @ cure jan \ ae Nga eae wt EQuipmeFactory Ac FAT-IE210118-111 Date: 28™ May 2019 + RaValue Test: oo? ¢ es Internal Surface um | External Surface um Saisfied 7 Not Satisfied Signature © Mixing Record of results: RPA 00 [1000 7300 | 1600 | 2400 | 2800 Mixing Mixing - Gentle or Vigorous Satisfied 7 Not Satistied Signature Top Mounted anchor 14 RPM ans Co ee he G of Wee i Record of results [Rem 7 24 38 46 38 [Mixing Mixing - Gentle or Vigorous, Satisfied T Not Safisfied Signature CuENT EQUIPMENT18-1115 Date: 28" May 2019 2) Wax Phase Vessel » PHYSICAL / DIMENSIONAL VERIFICATION GA Drawing Verification: Satisfied / Not Salisfied Signature P&ID Drawing Verifica Satisfied 7 Not Satisfied ‘Signature + Vessel - Hydro Tost: (Test Pressure{$.9 bar) = < Duration 30 \herv Holdup Pressure Bar Satisfied 7 Not Satisfied Signature im 6 oa! (ot ‘ «Jacket — Hydro Test: (Test Pressure: 3.9 ba Oa eae [Holdup Pressure ___._ Bar Satisfied 7 NotSatisfied | -—-Signature CUENT EQuipmeNT 0Factory Acceptan Prdtocnl - FAT-1E210118-1115 Date: 28" May 2019 + Ra Value Test: Internal Surface um Extemal Surface um Satisfied / Not Satistied Signature a s\ei2 xing pyar? + Mixin eS Bottom Mounted. fim 400 RPM to 1500 RPM Record of results: [RPM [Mixing Mixing - Gentle or Vigorous Satisfied 7 Not Satisfied ‘Signature CUNT ~ 2! EQUIPMENT ANT3) Water Phase Vessel + PHYSICAL / DIMENSIONAL VERIFICATION GA Drawing Verification: PID Drawing Verification: Satisfied 7 Not Satisfied date: 28" May 2019 Signature Satisfied 7 Not Satisfied FON + Vessel - Hydro Test: (Test Pressure/ 3.9 bar) Duration 20 sie —\\ Me Duration 30 cuenr— 3) EQUIPMENT in Signature Holdup Pressure Bar ] « Salisfied 7 Not Satisfied Signature yor ke ge we aN pe (ge? ( Holdup Pressure Bar Satisfied 7 Not Satisfied SignatureFacte p £210 y \ ww? + Ra Value Test: Va \e { Internal Surface um External Surface 7 ee Satisfied 7 Not Satisfied Signature Bottom Mounted Stirrer 400 RPM to 1600 RPM Record of results: RPM 600 | 7000 1300 [X10 [2400 [2800 [Mixing Mixing - Gentle or Vigorous Satisfied 7 Not Satisfied Signature CLIENT ~ BLOSSO EQUIPMENT ANUFAC LANT ~ 600KG