pharmaceutical facility engineering
TRANSCRIPT
Pharmaceutical Facility Engineering &
Turnkey solution Date :
Project :
By Umesh Deshmukh………
To become one of the trusted partner in
Pharmaceutical Industry
• Collaboration • Creativity • Innovation • Informed
Practices • Professionalism • Integrity
• Collaborate with client to create long terms business goal
• Support Human lives for affordable medicine
• Industry Benchmarking to stay ahead of Competition
Journey……… 22 Years Experience in Core Pharma Industry to design and Build many expansions and Greenfield Projects as per statutory requirement of EU GMP & FDA Guidelines.
Organizations • Cipla Ltd • Mondelez – USA. • Dr. Reddy’s Laboratories Ltd • Teva Pharma – India/Israel • Piramal Healthcare Ltd • Sun/Ranbaxy Pharmaceuticals • Sophal SPA. - Algeria • Ethypharma - France • Dabur Pharma • Acculife (Nirma) Healthcare • SDS Pharmaceutical • Pharmix/Oxycare Turkey
PHARMA GLANCE
PHARMA GLANCE ………. formed 2016
Current Projects – 2020…………
OSD Facility Expansion , Filling Line and Warehouse (BUDGET – 3 MN USD) – Designing & Cleanroom Material Supply.
Facility Creation for Inhalation/Anaesthetic/Eye drop product (BUDGET – 15 MN USD) – Designing & Electrical Material Supply.
New Facility for API Powder (BUDGET – 200,000 USD) – Design & Turnkey Supply.
New Biotech Plant Project – With Bioprocess and Final Packaging in Vials – 6.5 Million USD. Project is in Preliminary Design stage. (TURKEY)
Past Projects – SOPHAL SPA, Oran Algeria. Approx. 20 Mn (Project Value - 2015-2019)
Core Strength Our Uniqueness in this industry is, Our entire team is well experienced and worked in Pharma Industry in various segment, i.e. Projects / Process / Regulatory / Validation / CQA / Microlaboatory and Compliance.
Our Average experiences in Pharma industry is 20+ Years (Strong Process and technology know how)
Build and Demonstrated more efficient facility to face Industry competition and Operation.
Most Optimized Capital Investment & Industry Bench marking in terms of Opex, Efficiency & sustainable output based on last 25 Projects.
Extensive experience is design and execution of Facilities for Different dosage forms like Sterile Injectables, OSD, Cream and Ointment, Liquid, Cephalosporine, Biotechnology, Potent and Hormonal Products.
We resource the Global material with reputed brand, Quality and major concern with Cost Conscious.
We do design in terms of process / functioning and Optimization of the available space and even usages of every corner of the facility.
We, Keen to provide Value addition for project layout and its compliance.
Wide Experience in Regulatory Compliance on Facility and Face Audits from USFDA, HMRA, TGA, ANVISA, WHO.
Recourses • Office Staff - 12 (Specialized in Process, Regulatory, HVAC, Electrical, Clean Utility, Plant Design, Documentation & Drafting)
• Qualification Team – 4 (Operating from South Africa & INDIA – Complete Validation Vertical )
• Site Execution Team – More than 70
Organization Vertical……………
• VALIDATION & QUALIFICATION: Qualification & Validation of the Facility as well as Process is leading by Mr. Rajesh Pai with his dedicated team.
• PROCESS VERTICAL: Process Description and Layout freezing with respect to the Optimization of the foot print of the equipment's , Man
and Material movement and Process uniform Flow considering cGMP Practices is leading by Mr. JG & Mr. Ahmed .
• PROJECT ENGINEERING & DEVELOPEMENT: Project design / Procurement / Execution and Drawing & Documentation pertaining to the Project activity and also
Import / Export of the Material from the Globe, is leading by Mr. Umesh Deshmukh & Mr. Vinay Gowande.
• MANUFACTURING: • Patented Terminal HEPA Filter assembly for HEPA Filter and Clean room lights.
• Silicone Carbide impregnated Epoxy Floor – Multicolor Technology and hardness and strength is 1.5 times more
than normal Epoxy.
• Clean Room Light Fixtures – Top & Bottom Openable
• Dynamic Pass boxes / Warehouse Racking / SS Accessories / Injectable Plant HEPA Garment Locker / LAF / BSC.
Design Regulatory Compliance
• Comprehensive compliance report for facility design.
• We can highlight the risk and mitigation plan for all critical operation.
• Evaluate the every aspect of the EU Guidelines with respect to Facility Design optimization.
• Adopt the policy and practices of documentation by process & design, to avoid manual writing & errors.
• Our expertise:
• Faced many Regulatory Audit during while Project / Maintenance and in Production which converts our
implementation into optimized engineering solution.
• Less depend upon procedural control and introduce engineering solution for better compliance.
( Example - Batch Report / RH &Temp Report / Cleaning checklist displayed on machine itself)
• Format change over procedure linked with HMI Direct.
• Low End Technology – 1600 US $
• High End Technology – 1800 US $
• Low End Technology – 1500 US $
• High End Technology – 1600 US $
Capital cost /
SQM (Without Equipment’s
& Civil Construction)
• Space Required – 90-100 SQM • Space Required - 1.2-1.5 SQM./Mn. SQM / Mn
Output
• $ 0.4 / Unit • $ 3.5 / 1000 Units
Operation Cost
in US $ (Consumable+Manpo
wer+Energy Cost)
• HVF – 0.72 – 0.75 Mn / HC
• LVF – 0.45 - 0.48 Mn. / HC
• HVF – 25-27 Mn. / HC
• LVF – 15-17 Mn / HC
Capacity (Mn.)
/ Head count (Annual Capacity)
OSD STERILE
Industry Benchmark- Capex, Efficiency Indicator & Profitability
Brands we are Providing from Globe ……… SR.NO. ENGINEERING SPEICIFICATOIN ITEM MAKES
1 CLEAN ROOM PARTITION PARTITION & DOORS I CLEAN / GUSU OR EQUIVALENT
2 HVAC AIR HANDLING UNIT FLAKTWOOD / CITIZEN / DJK
BMS SIEMENS/HONEYWELL
PREINSULATED DUCT P3 ITALIAN OR INDIAN
HEPA FILTERS AAF / CAMFILL
3 ELECTRICAL ELECTRICAL PANEL SCHNEIDER / SIEMENS
CABLE POLYCAB OR AVOCAB
UPS DELTA / EMMERSON
LIGHT FIXTURES LED PHILLIPS / BRIDGELUX
4 MECHANICAL PIPING JINDAL
VALVES & ACCESS. AUDCO & EQUIVALENT
INSULATION ARMACELL OR EQUIVNT.
GAUGES WAREE / GURU
5 EXTRA LOW VOLTAGE FIRE ALARM SYSTEM SIMENTS OR EQVALNT.
CCTV HONEYWELL OR EQVANT.
DOOR INTERLOCKING PHARMAGLANCE
IT CORDS & PATCHES SIEMENS OR EQVALENT.
6 UTILITY EQUIPMENTS BOILER FORBES MARSHALL
AIR COMPRESSOR ATLAS COPCO
CHILLER CARRYAIRE / TRANE
PUMPS GRUNDFOS/ARMSTRONG
HOT WATER SYSTEM FORBES MARSHAL
NITROGEN SYSTEM AIRO ENGG OR EQVALENT
PUW / WFI & PSG INDIAN BRAND WITH IONPURE ITEMS
TRANSFORMER & DG PARKINSON/VOLTAMP
WATER TANKS & RECEIVER PHARMAGLANCE
7 FLOORING PU FLOORING DR BECK INDIA OR REPUTED
Footprint
Johannesburg SA
Cairo, Egypt
Hyderabad, India
New Jersey USA
Shanghai, China
Hadramout, Yemen
Services – One Stop Solution
Facility Design
Turnkey Solution
Qualification
Client list – Working for and worked for
Our Key Team Members :
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Master Degree in Operation
Management and Graduate
Engineering in Mechanical. Over 22
Years experience and expertise in
facility design and great
Exposure in Pharma Guidelines
and Operation.
HYDERABAD, INDIA.
+91 7032920203
PG Diploma Certification in
Marketing and Sales and having
16+ Years experience in
international business forum for
Pharmaceutical Project
Management & Equipments; &
expertise in CRN.
HA AHMEDABAD, INDIA
+91 9898134902
UMESH DESHMUKH AHMED HAMDY ANANT GOKHALE Doctorate in Pharmacy and
Over 17 Years highly
appreciable experience in
the field of OSD / Injectable
and in implementing as a
Lean Six Sigma Green
belt, KAIZAN & 5S.
CAIRO, EGYPT.
+20 100 6505960
RAJESH PAI Graduate in Pharmacy and
Member Of ISPE and PDA.
Over 20+ Years experience in
the field of Process Validation,
and Training for Audit & Gap
Analysis.
JOHANNSNBERG, SA.
+27 794618031
VINAY GOWANDE Masters in Manufacturing
System and BS in ENGG. 25+
years of hands-on experience
in manufacturing vertical and
keen on Business process
analysis and process
reengineering.
NJ, USA.
+11 610-533-5260
We could be your choice of business partner
1. 301, Sai Ambience, S. No. 60/78, Pimple Saudagar, Pune-411027, MAH. INDIA
2. Sri Sai Dhatri Heights, Pragathi Nager Road, Kakatiya Hills, Hyderabad, Telangana, India - 500090
[email protected] [email protected] [email protected]
+91 7032920203 +91 7032646203
www.Pharmaglance.com