Company profile
Contact details
ToDate: 22.10.09
M/s
Sub: Introduction letter.
Dear Sir,
I would like to introduce myself as a competent pharmaceutical Professional having 6 years of experience with pharmaceutical Projects, Machinery & Utilities. I had started my career as a Project engineer in 2002 and gradually able to handle turnkey projects individually since 2004.majority of the projects executed are with sterile facility for liquid Injectable or dry powder Injectable, other than specialized projects for potent drugs like hormones, anti cancer drugs ONCO Projects for toxic drugs.
I have been exposed right form conceptualization of the project to commissioning & of the projects executed are:
M/s Pharma Swede ( Liquid Injectable): Egypt
M/s Mobidco( Liquid Injectable): Jordan
M/s U ...topia ( Liquid Injectable): Bangkok
M/s Asia Pharma ( Dry Powder Injectable): Syria
M/s Cello Pharma ( Dry Powder Injectable): Brazil
M/s Nitin Life Sciences ( Liquid Injectable): Ponta Sahib, India
M/s Nitin Life Sciences ( Dry Powder Injectable): Ponta Sahib, India
M/s Health Bio- Tech( Liquid Injectable): Baddi, India
M/s Scott Edil( Liquid Injectable) : Baddi, India
M/s Strides Acrolab( Onco Projects): Bangalore, India
M/s Star Drugs( Onco Projects): Bangalore, India
M/s DRL( Onco OSD Projects): Vizag, India
M/s Srinivas Pharma( API Onco Projects): Vizag, India
M/s Panacea Bio Tech( OSD Onco Projects): Mumbai, India
M/s Panacea Bio Tech( Onco Injectable Projects): Mumbai, India
M/s Serum Institute( Customize Glove Box): Pune, India
Our strengths are:
Conceptualization of the project.
Detailing of the project at micro level to find critical path & Process Flow.
Project planning with control techniques.
Utility Detailing.
Validation of process Equipment. (LAF, RLAF, Dynamic Pass Box, Sterilizing tunnel, DHS, Autoclave, Isolator)
1)DOP
2)Particle Count.
3)Air velocity.
4)Temperature Profile.
Report generation as per ISO standards.
Complete Automation for plant d party inspection.
In addition to above, in depth knowledge of BMS & its system integration with all process control parameter & logic development with area facturing Strength:
Designing of Bio-Scrubber
Designing of Dust Collector
Designing of AHU (At Conventional & Containment Level)
Designing of Capsule Line & Automatic High Speed Tablet Inspection Machine.
Design & development for Containment system (Isolator) for OSD & liquid Injectable section.
Hence, I request you to consider me as competent professional for offering the services as per URS.
Thanks Regards,
Sibasish Mahapatro
For GroyneTech
Project Management Services:
A.Project Management:
Project planning, scheduling, monitoring, expediting and periodical reporting, highlighting areas of concern.
Recommending remedial action for achieving schedules.
Coordination with various project disciplines, consultants and vendors.
Expediting timely receipt of drawings and approvals from vendors, consultants, and owners.
Ensuring preparation of AS BUILT drawings, statutory documents.
Completion and submission of final project documentation.
B. Procurement and inspection:
Preparation of vendor evaluation, short listing, and recommendation of vendors.
Preparation of enquiries for plant and machinery.
Floating enquiries, obtaining techno commercial clarification and preparation of comparative statement of offer.
Assistance in negotiations with vendors and order finalization.
Stage wise and final inspection and acceptance at vendors premises and at site.
Expediting and progress chase up with vendors and submission of periodical progress reports and management reports.
C. Site management:
Construction scheduling, monitoring, and control.
Quality control during construction.
Ensuring safe work practices.
Progress monitoring and vendor control.
Quantity measurements.
D. Validation and Documentation:
Preparation of documents like URS / FDS / IQ / OQ / VP/ IOM for process equipments and critical utilities.
Preparation of preventive maintenance schedules and concerned S.O.Ps.
Validation of critical equipments like sterilizers with IMPORTED DATA LOGGER, which compiles with 21 CFR PART 11.
Calibration of thermo couples and pressure gauges.
E. H.V.A.C Design and validation;
Heat load calculations for complete facility.
H.V.A.C zoning and pressure differentials.
Airflow calculations based on A.C.P.H and bleed / fresh air and sizing of A.H U.
Clean room design with location / type of supply and return air.
Bill of material for all variables for down stream portion of H.V.A.C.
Periodic inspection of the work progress and highlighting of areas of concern.
Pressure balancing techniques.
Validation of complete H.V.A.C.
F. Utility Specification Freezing, Design, & Installation:
Calculation of Electrical load of Plant.
A)Lighting Load
B)Equipment Load.
C)Generator Load.
D)UPS Load.
Calculation of Raw Water System:
D.M. Plant Design.
Calculation of Compressor system.
Calculation for Steam Plant.
We trust that you will appreciate this methodology. Read more
M/s
Sub: Introduction letter.
Dear Sir,
I would like to introduce myself as a competent pharmaceutical Professional having 6 years of experience with pharmaceutical Projects, Machinery & Utilities. I had started my career as a Project engineer in 2002 and gradually able to handle turnkey projects individually since 2004.majority of the projects executed are with sterile facility for liquid Injectable or dry powder Injectable, other than specialized projects for potent drugs like hormones, anti cancer drugs ONCO Projects for toxic drugs.
I have been exposed right form conceptualization of the project to commissioning & of the projects executed are:
M/s Pharma Swede ( Liquid Injectable): Egypt
M/s Mobidco( Liquid Injectable): Jordan
M/s U ...topia ( Liquid Injectable): Bangkok
M/s Asia Pharma ( Dry Powder Injectable): Syria
M/s Cello Pharma ( Dry Powder Injectable): Brazil
M/s Nitin Life Sciences ( Liquid Injectable): Ponta Sahib, India
M/s Nitin Life Sciences ( Dry Powder Injectable): Ponta Sahib, India
M/s Health Bio- Tech( Liquid Injectable): Baddi, India
M/s Scott Edil( Liquid Injectable) : Baddi, India
M/s Strides Acrolab( Onco Projects): Bangalore, India
M/s Star Drugs( Onco Projects): Bangalore, India
M/s DRL( Onco OSD Projects): Vizag, India
M/s Srinivas Pharma( API Onco Projects): Vizag, India
M/s Panacea Bio Tech( OSD Onco Projects): Mumbai, India
M/s Panacea Bio Tech( Onco Injectable Projects): Mumbai, India
M/s Serum Institute( Customize Glove Box): Pune, India
Our strengths are:
Conceptualization of the project.
Detailing of the project at micro level to find critical path & Process Flow.
Project planning with control techniques.
Utility Detailing.
Validation of process Equipment. (LAF, RLAF, Dynamic Pass Box, Sterilizing tunnel, DHS, Autoclave, Isolator)
1)DOP
2)Particle Count.
3)Air velocity.
4)Temperature Profile.
Report generation as per ISO standards.
Complete Automation for plant d party inspection.
In addition to above, in depth knowledge of BMS & its system integration with all process control parameter & logic development with area facturing Strength:
Designing of Bio-Scrubber
Designing of Dust Collector
Designing of AHU (At Conventional & Containment Level)
Designing of Capsule Line & Automatic High Speed Tablet Inspection Machine.
Design & development for Containment system (Isolator) for OSD & liquid Injectable section.
Hence, I request you to consider me as competent professional for offering the services as per URS.
Thanks Regards,
Sibasish Mahapatro
For GroyneTech
Project Management Services:
A.Project Management:
Project planning, scheduling, monitoring, expediting and periodical reporting, highlighting areas of concern.
Recommending remedial action for achieving schedules.
Coordination with various project disciplines, consultants and vendors.
Expediting timely receipt of drawings and approvals from vendors, consultants, and owners.
Ensuring preparation of AS BUILT drawings, statutory documents.
Completion and submission of final project documentation.
B. Procurement and inspection:
Preparation of vendor evaluation, short listing, and recommendation of vendors.
Preparation of enquiries for plant and machinery.
Floating enquiries, obtaining techno commercial clarification and preparation of comparative statement of offer.
Assistance in negotiations with vendors and order finalization.
Stage wise and final inspection and acceptance at vendors premises and at site.
Expediting and progress chase up with vendors and submission of periodical progress reports and management reports.
C. Site management:
Construction scheduling, monitoring, and control.
Quality control during construction.
Ensuring safe work practices.
Progress monitoring and vendor control.
Quantity measurements.
D. Validation and Documentation:
Preparation of documents like URS / FDS / IQ / OQ / VP/ IOM for process equipments and critical utilities.
Preparation of preventive maintenance schedules and concerned S.O.Ps.
Validation of critical equipments like sterilizers with IMPORTED DATA LOGGER, which compiles with 21 CFR PART 11.
Calibration of thermo couples and pressure gauges.
E. H.V.A.C Design and validation;
Heat load calculations for complete facility.
H.V.A.C zoning and pressure differentials.
Airflow calculations based on A.C.P.H and bleed / fresh air and sizing of A.H U.
Clean room design with location / type of supply and return air.
Bill of material for all variables for down stream portion of H.V.A.C.
Periodic inspection of the work progress and highlighting of areas of concern.
Pressure balancing techniques.
Validation of complete H.V.A.C.
F. Utility Specification Freezing, Design, & Installation:
Calculation of Electrical load of Plant.
A)Lighting Load
B)Equipment Load.
C)Generator Load.
D)UPS Load.
Calculation of Raw Water System:
D.M. Plant Design.
Calculation of Compressor system.
Calculation for Steam Plant.
We trust that you will appreciate this methodology. Read more
Category
- Organizer