fusion scientific - presentation · milestone-high performancemicrowave digestion system sample...
TRANSCRIPT
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Corporate Presentation
Formulation Development
Analytical Development / Services
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Contents
• Facility
• Company Brief
• Services offered
• Formulation Development Services
• Analytical Development Services • Analytical Development Services
• Quality Assurance
• Project Management
• Global Presence
• Location
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Facility
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Company Brief � Fusion Scientific is an independent knowledge based organization having around 18,000
sq. ft. premises located in Navi Mumbai. Our focus is on Pharmaceutical Development
and Analytical Development/Services.
� Fusion has successfully cleared USFDA Audit in 2015 at Previous facility same has been
extended to the new facility at Rabale .extended to the new facility at Rabale .
� The group, established in 2011, is promoted by technocrats having vast experience in
the related fields. We combine Science, Innovation and People to help our clients
address their development related challenges.
� Privately owned Ltd. Company
� Highly qualified personnel
� ISO 9001:2015
� GLP- Conformity
� Local FDA approval
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Services Offered
� Formulation Development
� Analytical Method Development
� Analytical Method Validation
� Analytical testing
� Technology Transfer
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Formulation Development Capabilities
• I.R. (Immediate Release) Tablets:
� Single layer and multi-layered
� Uncoated, film coated and sugar coated
� Effervescent tablets
• Low Dose
• Modified Release Tablets and Capsules:
� Delayed Release Tablets
� Extended Release Tablets/Capsules
• Semi Solids and Topical Products
• Liquid Dosage Forms such as Syrup, Suspension etc.
• Ophthalmics
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Formulation Development – Scope of work
� Literature & Primary Patent Evaluation
� Pre-formulation Studies and Innovator Product Evaluation
� Galenical Formulation Development
� Formulation Optimization
� Process Optimization
� Technology Transfer to CMO Site
� Documentation support in CTD Formats
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Project Initiation
Formulation Development
Logistics Analytical Development
Patent evaluation,
literature survey
Application to FDA for test license, DCGI for Import License, NOC
etc.
API Qualification
Strategy development Receipt of API,
reference products,
Product Development Flowchart
Reference product and API
evaluation
reference products, innovator product, working standard,
excipients etc.
Pre-formulation prototype
development
Analytical Method Development
Prototype selection and scale up/process
optimization
Pilot Bio study
Reference product evaluation
Prototype trial/batch analysis
Stability study
Analytical Method Validation
T.T. documentationT.T. documentation
Tech Transfer Support
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Formulation Development Equipment List
� Rapid Mixer Granulator
� Fluid Bed Drier
� Cage/ Octagonal Blender
� Compression Machine (Single / Bilayer)
� Roll Compactor
� Auto coater
� Pam Capsule Filling Machine
� Blister Packaging Machine
� Availability of Low Humidity Area
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Analytical Services
Pharmaceuticals Industry :
� Analytical Method development and Validation of APIs and finished dosage forms by
HPLC/GC/AAS/ICPMS/IC/GCHead space- MS
� Stability studies as per ICH guidelines
Dissolution profiling� Dissolution profiling
� Pharmaceutical analysis as per IP, USP, EP, BP etc.
� Residual Solvent Validation / Testing
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Analytical Lab – Instrumentation List
� HPLC’s with UV, PDA and RI detectors
� GC with Head Space and Liquid Injector
� GC head space-MS
� Thermo ICPMS
� Microwave digestion system � Microwave digestion system
� Ion Chromatography
� UV visible Spectrophotometer
� Atomic Absorption with Hydride Generator
� Stability Chambers with 1000 litres capacity
� Dissolution Apparatus
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ICPMS- Inductively coupled plasma mass spectrometry
� January 1, 2018 was the new date of applicability for USP
General Chapters <232>, <233> and <2232> along
with the ICH Q3D guidance.
� To meet these requirement of testing
elemental impurities in the pharmaceutical products elemental impurities in the pharmaceutical products
new analytical protocols using
Inductively coupled plasma mass spectrometry (ICP-MS)
is method of choice.
� With this analytical technique –testing and validation
can be performed in raw material (API and excipients) and Finished dosage form
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Milestone-High performance microwave digestion system
� Sample preparation is a fundamental step towards a successful
analysis and its importance can not be underestimated.
� The ETHOS UP is specifically designed;
� for high pressure, closed vessel acid digestion- thisfor high pressure, closed vessel acid digestion- this
Approach helps in retention of volatile elements.
� High safety
� Fast digestion
� Low quantity of acid required ensuring accurate results
� Multiple sample analysis without cross contamination
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Ion Chromatography -Dionex
� The Thermo Scientific™
Dionex™ ICS-5000+ System
Ion chromatography is a well-established
technique used for analyzing anions andtechnique used for analyzing anions and
cations in pharmaceutical, environmental,
food and many other samples.
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GC HS –MS- Gas chromatography Head space mass
spectroscopy
� Recently several Sartan group of drug products intended for Angiotensin II receptor
block (ARB) were recalled based on the observations for the presence of following
Nitrosamines in finished goods as potentially carcinogenic impurities as a contaminant.
�N-Nitrosodimethylamine (NDMA)
� N-Nitrosodiethylamine (NDEA)
� N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)
� Nitrosodibutylamme (NDBA)
� N Nitroso di isopropylamine (NDIPA)
� N-Nitroso Pyrrolidine
� N Nitroso ethyl iso propylamine (NEIPA)
� N-Nitrosomorpholine
� N-Nitroso di propylamine (NDPA)
� N-Nitroso Piperidine
� Fusion is leading Analytical testing laboratory and can utilize established USFDA issued
methods for above listed impurities and also ready to support for development and
validation of above listed impurities in drug substance and drug products.
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Quality Assurance
� Independent Quality Assurance department.
� Responsible for driving the Quality Management systems.
� Ensuring the GDP and GLP practices are implemented and followed.
� Monitoring the calibration activities as per Calibration schedule.
� Ensuring Periodic SOP trainings .
� Periodic internal audits are conducted and driven by Quality Assurance.
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Project Management
Project management team with experience in various aspects of pharmaceutical field are
responsible for the following activities,
� Single point of contact for communication with Client
� Co-ordinate the on going project related daily activities
� Provide biweekly project updates to Client by email/telecons
� Ensure to achieve the committed project timelines
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Global Presence
CANADA
USA
UK
GREECE
TURKEY
RUSSIA
CHINAGCC
Currently working on Formulation Development Projects for the above markets on
AUSTRALIA
GCC
South Africa
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FUSION SCIENTIFIC LABORATORIES PVT. LTD.
Plot No. R-656 -TTC Industrial area,
MIDC Rabale,
Navi Mumbai – 400701
Maharashtra, India.
Email: [email protected]
Website: : www.fstin.com
� ~25 km from Mumbai International Airport
Contact Person Contact details
Mr. Manohar Kotwani Email id: [email protected]
Mobile No.: +91 9819075071
Mr. Deepak Patel Email id: [email protected]
Mobile No.: +91 9892086409
Ms. Rashmi Prasade Email id: [email protected]
Mobile No.: +91 9820740366
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