Shiva Analyticals (India) Private Limited · Market leader in Geochemical and trace metal analysis...

Company Confidential Slide 1

Shiva Analyticals (India) Private LimitedPharma Lab Services

Sep, 2018

Shiva Analyticals(A Cotecna Group Company)

Established 40,000 sq. ft. state-of-the-art laboratory in 1997

Market leader in Geochemical and trace metal analysis

Global Foot Print

Serving clients across 5 continents

Member of WAITRO (World Association of Industrial and Technological Research Organizations)

ISO 9001: 2015 Certified

ISO/IEC 17025: 2005 Accredited

OHSA 18001 Certified in 2013

Recognized Lab for Ph.D. program by Tumkur University, Karnataka


Over v iew



First commercial Laboratory in India to start ICP- MS analysis in 1997

First Third Party Lab to provide Fire Assay Test facilities in India

Participating Laboratory in Certification of Inorganic Reference Standards

Strategic tie-ups with International/National Labs for Advanced Material Analysis i.e. Glow Discharge Mass spectrometry

Contract Research


Highl ights


IntegrityIntegrity

QualityQuality

ComplianceCompliance

ServiceExcellenceService

Excellence

Customer Satisfaction Customer

Satisfaction

Our Core Values

"A customer is the most important visitor on our premises. He is not dependent on us. We are dependent on him. He is not an interruption of our work. He is the purpose of it. He is not an outsider of our business. He is part of it. We are not doing him a favour by serving him. He is doing us a favour by giving us the opportunity to do so.“

- Mahatma Gandhi in a speech in South Africa in

1890


Company Confidential 5

Global Footprint in 2018Serving customers in 20 countries and 5 continents

North AmericaUnited States of America (8 Locations)

Canada

South AmericaBrazil

Columbia

EuropeLuxembourg

Asia PacificJapan

IndonesiaSingaporeMalaysiaThailand

China

Africa & Middle EastTanzaniaZambiaCongoNigeriaOman

Botswana



Minerals & Ores

Materials

Pharmaceuticals

Food & Beverages

Industrial Hygiene

Fuels & Oils



Pharmaceuticals



ISO/IEC:17025 (2005)

ISO 9001: 2015

Facility audited by USFDA in 2007 & 2016

Department of AYUSH

Karnataka Drug Control Department

OHSMS 18001: 2007

Accreditat ions/Cert i f icat ions


Facility is Registered and Site Self Identified with USFDA

Data Management through Agilent Open Lab ECM Software

100% data generated during analysis are Audit Trailable

Real-time auto backup of data on the server

Caliber LIMS 3.2.1 version roll out is in progress

Dedicated cGMP area with access controls

HPLCs, GCs, LCMSMS, GCMSMS, FTIR, UV, ICPMS, ICP-OES, AAS and Stability Chambers are compliant and connected with ECM to Server


cGMP & 21 CFR Part 11 Compl iant Lab


Data Integrity : cGMP - 21 CFR Part 11 Compliance

Slide 10 Company Confidential


Pharmacopoeial testing of Raw Materials, Intermediates & Finish Products

Products Tested as per USP, BP, EP, IP Methods and Customers Requirements

Products Tested Tablets Capsules Eye drops

Syrups etc.

Test Parameters Identification Physical parameters Assay test Related substances Impurity profiling Dissolution test Disintegration test


Core Competencies


Stability Studies as per ICH Guidelines

Long-term stability at 25°C / 60% RH,

Intermediate stability at 30°C / 65% RH

Accelerated stability at 40°C/ 75% RH

Analytical Method Development & Validation

Stability indicating assay Related substances / Degradation Products Residual Genotoxic impurities Residual solvents / Volatile Organic impurities Residual catalysts / metals Wet chemical analysis Dissolution studies Content uniformity


Core Competencies


Impurity Quantification

LC-MS/MS, GC-MS/MS

Heavy Metal Analysis

ICP MS, ICP OES, AAS

Residual Genotoxic Impurities in API & Formulations

Nitrogen and Compressed air analysis in GMP compliant lab

BET surface area & average porosity analysis

Pesticide Residue and Aflatoxin Analysis

GC-MSD / LC-MS/MS / HPLC-FLD

Wet Chemical Analysis

Metrohm Auto-Titrator


Core Competencies


Extractable and Leachables Study

Residual Ethylene Oxide Test

Heavy metal analysis


Packaging Mater ia l & Medical Devices Test ing


Spectrometers

AAS - Agilent 200 Series GTA 120 Graphite Furnace

ICP OES - Perkin Elmer 5300DV

ICP MS - Agilent 7700


Instrumentat ion


UPLC H-Class/MS/MS – Waters TQS Micro

LC/MS/MS - Agilent 6410 Triple Quad Mass Spectrometer

GC/MS/MS Purge & Trap - Agilent 7000 Series Tekmar

GC/MS (5977A) Head Space - Agilent 7697A


Chromatography

Instrumentat ion


GC with FID and TCD detectors - Agilent 7890

HPLCs with UV-Vis, PDA, FLD and RI detectors - Agilent 1260 and Waters e 2695

Ion Chromatography – Dionex ICS 5000+ with Conductivity detector


Chromatography

Instrumentat ion


FT- Infrared Spectrophotometer - Agilent Cary 630

UV-ViS Spectrophotometer - Agilent Cary 60

BET Surface Area Analyzer - Micromeritics Gemini 2390t


Spectroscopy, Thermal & Surface Techniques

Instrumentat ion


Company Confidential 19

Cl ients Ser ved



Shiva Analyticals (India) Private Limited

Plot No: 24D(P) & 34D, KIADB Industrial Area, Hoskote, Bangalore - 562 114Karnataka, INDIA

Tel: +91 080-28015333; Fax: +91 80 27971321Email: [email protected]

Website: www.shivaanalyticals.com

Contact us


Shiva Analyticals (India) Private Limited · Market leader in Geochemical and trace metal analysis...

Documents

Transcript of Shiva Analyticals (India) Private Limited · Market leader in Geochemical and trace metal analysis...