SINGLE STOP SOLUTION FOR RESEARCH SERVICES INNOVATION IS OUR - - PowerPoint PPT Presentation

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SINGLE STOP SOLUTION FOR RESEARCH SERVICES INNOVATION IS OUR - - PowerPoint PPT Presentation

Nov 20, 2023 344 likes •827 views

SINGLE STOP SOLUTION FOR RESEARCH SERVICES INNOVATION IS OUR CULTURE QUALITY IN OUR GENES SIPRA LABS LIMITED ACCREDITATIONS OF SIPRA TGA- AUSTRALIA HEALTH CANADA (HC) DRUG CONTROLLER GENERAL OF INDIA (DCGI) NATIONAL ACCREDITATION BOARD FOR

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SINGLE STOP SOLUTION FOR RESEARCH SERVICES

INNOVATION IS OUR CULTURE QUALITY IN OUR GENES SIPRA LABS LIMITED

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SLIDE 2

USFDA (WAITING FOR RENEWAL)

TGA- AUSTRALIA

HEALTH CANADA (HC)

DRUG CONTROLLER GENERAL OF INDIA (DCGI) NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (NABL) OECD GOOD LABORATORY PRACTICES (GLP)- (INSPECTED)

ACCREDITATIONS OF SIPRA

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SLIDE 3

Our Commitment Our Vision

We are committed to delight customers by providing services that excel the expectations in terms of quality, speedy delivery and competitiveness To continuously improve

  • ur Research Services, Infrastructure,

Regulatory Compliance and Customer Support

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SLIDE 4

SPECTRUM OF RESEARCH SERVICES

23-May-17 4

Bioequivalence / Bioavailability Food & Water Analysis Pre Clinical Toxicity Analytical Research & Microbiology Testing Formulation Research & Development Clinical Research

Medical Devices Testing

SIPRA

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SLIDE 5

SYNTHESIS DRUG/ DEVICE SCREENING IMPURITIES FORMULATION DEVELOPMENT PHASE-I PHASE-II PHASE-III DOSSIER STABILITY & SHELF LIFE

KEY ACTIVITIES OF SIPRA

Structure Elucidation, Mass, CHNSO, XRD, DSC, TGA, NMR Rats, Mice, Rabbits, Beagle Dogs

Organic-LC - MS/MS, GC-MS/MS, Residual - GC Headspace, Inorganic - ICP-MS, AAS

Tablets, Capsules, SR Products Accelerated , Intermediate and Long Term Studies 12 Bed Facility, Continuous Monitoring, Metabolic, Respiratory Cardiac Laboratories 100 Beds Bioequivalence Center Expertise in Respiratory, Anesthesia tied up with 15 centers Submitted 15 Dossiers for South Africa and 10 in India

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SLIDE 6

ANALYTICAL EXPERTISE

FIRST CHOICE ANALYTICAL LABORATORY MORE THAN 100 QUALITY AUDITS PER YEAR TWO DECADES OF EXPERIENCE CAPACITY TO TEST MORE THAN 10000 SAMPLES PER MONTH LARGEST COMMERCIAL ANALYTICAL TESTING LABORATORY SINGLE STOP INTEGRATED SOLUTIONS FOR ALL THE ANALYTICAL TESTING NEEDS STATE OF THE ART INFRASTRUCTURE GLOBAL LEADER IN ANALYTICAL TESTING MORE THAN 150 VALIDATED METHODS MORE THAN 12 MASS SPECTROMETERS COMPLETE REGULATORY ENVIRONMENT DEDICATED TEAM OF SCIENTISTS WITH INNOVATION AND EXPERTISE A TO Z EQUIPMENT FROM WORLD CLASS TRADERS cGMP COMPLIANT GLOBAL REGULATORY LABORATORY

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SLIDE 7

IMPURITY PROFILES

API 4000 LC-MS/MS GC Headspace with MS ICP-MS/MS Waters GC-MS/MS

Processing Impurities Inorganic Impurities Solvent Impurities

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SLIDE 8

METHOD VALIDATION ICHQ2.

  • Assay method validations
  • Related substance validation
  • Residual solvents by GCMS-Head Space & GCMS/MS
  • Trace elements validation using ICP-MS and AAS
  • Validation of Dissolution methods
  • Qualification of Genotoxic Impurities
  • Validation of Polymorphic methods
  • Particle Size methods
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SLIDE 9
  • Microbiological tests, assays as per USP, Ph. Eur, IP. Etc.
  • Screening of bacteria and virus
  • Bacterial endotoxin tests (BET) using gel clot and kinetic techniques and

validation.

  • Sterility testing using fully automated system eliminating any chance of

contamination using closed and open methods.

  • Validation of microbiological methods
  • Water (Process, Raw and Purified) analysis as per desired pharmacopoeias
  • Preservative efficacy testing (PET)
  • Antibiotic susceptibility and resistance studies
  • Microbial limit tests and sterility (Equinox closed system), RT – PCR studies.
  • Antibiotic and vitamin assays.

MICROBIOLOGICAL STUDIES

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SLIDE 10

Crystallography

Crystallinity By XRD % Amorphous Particle Size & Shape SEM Polymorphs XRD/Raman Liquid Born Particles Pore Size / Pore volume BET method Surface Area Particle Size Distribution Malvern

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SLIDE 11

BIOEQUIVALENCE/BIOAVAILABILITY STUDIES

  • Phase I to phase IV studies
  • 4 Clinics with a total of 120 beds
  • 20 beds ICU with central online monitoring
  • Central Nursing station with telemetric

monitoring, data recording & data retrieval

  • Web linking of ICU with medical experts
  • Bio-metric system for retrieval of data
  • Over 15,000 volunteer database
  • ICCU is equipped with ADR monitoring

and reporting

  • Recreational area for subjects
  • Adoption of GLP guidelines as per ICH

standards.

  • More than 100 Validated Methods
  • SAS (Ver 8.2), Pharsight WinNonlin (Ver 5.2.1)

Software for bio statistics

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SLIDE 12

BIOEQUIVALENCE/BIOAVAILABILITY STUDIES

  • Equipment:

LC-MS/MS (API- 4000, 3000,2000), GC MS Clarus-500, HPLCs with UV Fluorescence Detectors & Deep Freezer (-80oC) Fully Automated Immuno & Biochemistry Analyzer ELIZA Reader, X – Ray, Hematology Analyzer Electrolyte Analyzer, Urine Chemistry Analyzer E.C.G. & Deep Freezer – 25±5oC & -75± 5oC

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SLIDE 13
  • 12 Beds ICU, 3 Beds Special Care

Unit

  • Online monitoring of BP, ECG,

Pulse, Temp. and Oxygen using Real time SCADA system

  • Dynamic

Labs for Cardio, Respiratory and Insomnia

  • Central

Lab for Immunology, Biochemistry, Haematology and Urine Chemistry

  • CFR 21 part 11 compliant software
  • Password protected direct access

to sponsor

PHASE-I FACILITY

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SLIDE 14
  • PD/PK Studies
  • Multi Dose Studies
  • Multi Period Studies
  • Cosmetic & Safety Evaluation Studies
  • Urinary Drug Elimination studies
  • Drug-Food Interaction Studies
  • Drug-Drug Interaction Studies

BIOEQUIVALENCE STUDIES

DCGI approved facility Designed to meet world-class specifications Studies in strict compliance with global regulatory

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SLIDE 15
  • Association with 15 multi specialty hospitals
  • Protocol design & writing expertise
  • NIH-USA registered Independent Ethics Committee
  • Regulatory Approvals
  • NABL approved Clinical Laboratory
  • Respiratory, anesthesia cosmetic trial experience
  • Volunteer follow up & sample collection teams

PHASE-III CLINICAL TRIALS

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SLIDE 16
  • Polyethylene Terapthalate containers (PET bottles)
  • Polypropylene containers
  • High density polyethylene containers
  • Polyethylene containers
  • Glass containers
  • PP closers, Rubber closers and Aluminum seals
  • Aluminum Foil, Blister Packing, Laminated Pouches,

Corrugated boxes & Fiber Drums

PACKAGING MATERIALS

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SLIDE 17

PACKAGING MATERIALS

PHYSICAL TESTS

  • Description
  • Dimension
  • Brimful Capacity
  • Transparency
  • Color Migration
  • Visual Appearance
  • Identification of Material (IR, DSC)
  • Stock Load test
  • Memory test
  • Fatigue test
  • Fracture test
  • Friction Force test
  • Leak test
  • Pin Holes
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SLIDE 18

CHEMICAL TESTS

  • Acidity /Alkalinity
  • Chemical Resistance
  • Reducing Substances
  • Volatile Sulphides
  • Extraction Test

PACKAGING MATERIALS

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SLIDE 19
  • Heavy Metals
  • Trace Elements
  • Ammonium
  • Particulate Matter Counting

EXTRACTABLES & LEACHABLES

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SLIDE 20

PERFORMANCE TESTS

  • Permeability
  • Penetrability
  • Self Seal Ability
  • Vibration Test
  • Drop Test
  • Fragmentation
  • Tensile Strength
  • Bursting Strength
  • Environmental Stress Crack Resistance Test

(ESCR)

PACKAGING MATERIALS

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SLIDE 21

PRECLINICAL TOXICOLOGY SERVICES

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SLIDE 22

WE OFFER

PHARMACOPOEIAL TESTING

BIO ASSAY PYROGEN TESTING ABNORMAL TOXICITY ACUTE TOXICITY BIOLOGICAL REACTIVITY

PHARMACOKINETIC STUDIES TOXICITY STUDIES PHARMACOLOGICAL RESEARCH

MEDICAL DEVICE TESTING

ANTI INFLAMMATORY ACTIVITY ANALGESIC ACTIVITY CARDIOVASCULAR ACTIVITY DIURETIC ACTIVITY CYTOTOXICITY HEAMO COMPATIBILITY REPRODUCTIVE TOXICITY GENOTOXICITY AND CARCINOGENECITY SKIN IRRITATION SKIN SENSITIZATION IMPLANTATION SYSTEMIC TOXICITY ACUTE TOXICITY REPEATED DOSE TOXICITY DOSE INHALATION DERMAL TOXICITY IMMUNOGENICITY MUTAGENECITY GENO TOXICITY HALF LIFE BIO DISTRIBUTION BIO AVAILABILITY PERMIABILITY PROTEIN BINDING EXCRETION METABOLISM

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BIO COMPATIBILITY TESTING OF CATHETERS & STENTS AS PER ISO 10993 (>24h) SKIN SENSITIZATION SKIN IRRITATION ACUTE SYSTEMIC TOXICITY MATERIAL MEDIATED PYROGENICITY HAEMOCOMPATIBILITY SUB CHRONIC TOXICITY GENOTOXICITY CHRONIC TOXICITY CYTOTOXICITY IMPLANTATION CARCINOGENICITY BIO COMPATIBILITY TESTING OF DELIVERY SYSTEMS AS PER ISO 10993 (<24h)

MEDICAL DEVICES

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SLIDE 24

BARRIER BASED ENTRY DESIGN

  • Man
  • Materials
  • Cages Bedding
  • Test item
  • Animals
  • Controlled Air
  • Air Shower
  • Pass Box
  • Autoclave
  • Pass Box
  • Air Shower
  • HEPA filter
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SLIDE 25

LABORATORY EQUIPMENT

  • S. No.

NAME OF THE EQUIPMENT MAKE MODEL 1. ICP/MS/MS AGILENT TECHNOLOGIES G3271A 2. GC/MS/MS WATERS QUAPPRO 3. LC/MS/MS ABSCIEX API 6500 4. RT-PCR APPLIED BIO SYSTMES STEP ONE 5. IMMUNO CHEMISTRY ANALYZER ABBOTT AXSYM 6. 2D ELECTROPHORESIS BIORAD MINI SUB CELL GT 7. HEMATOLOGY ANALYZER (XP-100) SYSMTEX XP-100 8. BIOCHEMISTRY ANALYZER (XI-640) TRANSASIA ERBA XL-640 9. ROTARY MICROTOME LEICA RM2125RT 10. AUTOMATIC TISSUE PROCESSOR LEICA TP1020 11. PARAFFIN EMBEDDING STATION LEICA EG1150H 12. COLD PLATE LEICA EG1150C 13. ELECTRIC TISSUE FLOAT BATH LEICA TP1020 14. AUTO STAINER LEICA XL

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LITERATURE REVIEW PROTOCOL DESIGN REGULATORY CONCEPT DISCUSSION IAEC APPROVAL STUDY PLAN DISCUSSION STUDY CONDUCTION RESULTS REVIEW REPORT PREPARATION TECHNICAL REVIEW REGULATORY BODY APPROVAL

STUDY PLAN

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REGULATORY COMPLIANCE ROBUST QUALITY MANAGEMENT SYSTEM STRINGENT QUALITY CHECKS ADHERENCE TO QUALTIY AGREEMENTS SYSTEMATIC CONTROLS ON QUALITY SYSTEMS SELF ASSESSMENT BY INTERNAL AUDITS AS PER VALIDATION PLAN COMPLIANT MANAGEMENT DEDICATED QA TEAM- QUALITY IS OUR WAY OF LIFE CUSTOMER SATISFACTION RIGHT FIRST TIME AND RIGHT EVERY TIME

QUALITY ASSURANCE

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DECADE OF EXPERIENCE IN CONDUCTIN G OF STUDIES

20 STUDY ROOMS

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COMPLIANCE

COMPLIANCE FIRST

REGULATORY SIPRA SPONSOR

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SLIDE 30

SIPRA FIRST

SINGLE STOP SOLUTION FOR MEDICAL DEVICES RESEARCH SERVICES

DOG KINETIC STUDIES & RELEASE KINETICS WITH IN HOUSE PATHOLOGY & BIO ANALYTICAL LABORATORY MULTI NUMBER OF LC/MS/MS INSTRUMENTS COMPLETE REGULATORY ENVIRONMENT QUANTIFICATION OF METABOLITES USING HIGH SENSITIVE QTRAP 6500 LC/MS/MS

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DATA ARCHIVAL

DOCUMENTS TEST MATERIALS WET TISSUES BLOCKS SLIDES ARCHIVIST VERIFICATION OF DATA BY ARCHIVIST AND ASSIGNMENT OF REFERENCE NUMBER ARCHIVING

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MEDICAL DEVICE TESTING SERVICES

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BIO COMPATIBILITY TESTING OF CATHETERS & STENTS (VASCULAR & GASTRIC) AS PER ISO 10993 (>24h) SKIN SENSITIZATION SKIN IRRITATION ACUTE SYSTEMIC TOXICITY MATERIAL MEDIATED PYROGENICITY HAEMOCOMPATIBILITY SUB CHRONIC TOXICITY GENOTOXICITY CHRONIC TOXICITY CYTOTOXICITY IMPLANTATION CARCINOGENICITY BIO COMPATIBILITY TESTING OF DELIVERY SYSTEMS AS PER ISO 10993 (<24h)

BIOCOMPATIBILITY TESTING

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SLIDE 34

BILE DUCT STENTS ESOPHAGEAL STENTS DUODENAL STENTS COLONIC STENTS CLASSIFICATION OF GASTRIC STENTS GASTRIC STENTS FABRICATED BY METAL AND PLASTIC

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FACILITY

OECD GLP COMPLIANT FACILITY SINGLE STOP SOLUTION FOR ALL MEDICAL DEVICE TESTING NEEDS FACILITY WITH ROBUST ENVIRONMENTAL MONITORING SYSTEM FACILITY SPREAD OVER AN AREA OF 20500 Sft WELL DESIGNED DOG HOUSING FACILITY 20 ROOMS FOR CONDUCTING OF STUDIES ANIMAL SPECIFIC FACILITY FOR SMALL AND LARGE ANIMALS AS PER CPCSEA BARRIER MAINTAINED FACILITY

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SLIDE 36

DOG FACILITY

HOUSED WITH BEAGLE DOGS SEPARATE BUILDING FOR HOUSING SEPARATE AREA FOR DOG REHABILITATION ROBUST CONTROLLED ENVIRONMENT SUFFICIENT AREA FOR DOG RUN SEPARATE ROOMS FOR MALE AND FEMALE DOGS DOGS ARE HOUSED IN INDIVIDUAL KENNEL 5 SEPARATE ROOMS FOR EXPERIMENTATION

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SLIDE 37

STRENGTHS

DECADE OF EXPERIENCE IN CONDUCTING OF STUDIES

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EXPERTISE-MEDICAL DEVICE TESTING

RELEASE KINETICS FOR DRUG ELUTING STENTS TESTING OF ESOPHAGEAL, PANCREATIC AND DUODENAL STENTS NABL ACCREDITED PACKAGING MATERIAL TESTING FACILITY CHEMICAL TESTING AS PER ISO GUIDELINES MECHANICAL TESTING AS PER ASTM GUIDELINES OECD GLP COMPLIANT BIOCOMPATIBILITY TESTING

E X P E R T I S E

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SLIDE 39

LITERATURE REVIEW PROTOCOL DESIGN REGULATORY CONCEPT DISCUSSION IAEC APPROVAL STUDY PLAN DISCUSSION STUDY CONDUCTION RESULTS REVIEW REPORT PREPARATION

STUDY PLAN & EXECUTION

TECHNICAL REVIEW REGULATORY BODY APPROVAL

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SLIDE 40

CHEMICAL TESTING OF MEDICAL DEVICES

TESTING OF EXTRACTABLES AND LEACHABLES DETERMINATION OF ETHYLENE OXIDE RESIDUES CHEMICAL CHARACTERIZATION OF MATERIALS

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MATERIAL CHARACTERIZATION STENT DIMENSIONAL AND FUNCTIONAL ATTRIBUTES SHELF LIFE DELIVERY SYSTEM DIMENSIONAL AND FUNCTIONAL ATTRIBUTES

SURFACE CORROSION RESISTANCE PEAK TENSILE FORCE LIQUID LEAKAGE UNDER PRESSURE AIR LEAKAGE INTO HUB ASSEMBLY DURING ASPIRATION FLOW RATE THROUGH CATHETER BURST PRESSURE UNDER STATIC CONDITIONS POWER INJECTION TEST FOR FLOW RATE AND DEVICE PRESSURE SIDE HOLES DISTAL TIP OUTSIDE DIAMETER NOMINAL EFFECTIVE LENGTH SHAPE AND DIMENSIONS FRACTURE FRICTION FORCE MEMORY AND FATIGUE SHAPE MEASUREMENTS TENSILE FORCE VISCO ELASTIC PROPERTY (MEMORY TEST) NEEDLE HUB, CAP, TUBE, POINT FLOW RATE THROUGH THE NEEDLE BOND BETWEEN HUB AND NEEDLE TUBE NEEDLE BOND STRENGTH LUBRICANT TOLERANCE ON GRADUATED CAPACITY GRADUATED SCALE BARREL PISTON AND PLUNGER ASSEMBLY SYRINGE NOZZLE/NEEDLE

MECHANICAL TESTING OF MEDICAL DEVICES

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SLIDE 42

PACKAGING TESTING- ISO 11607

DISTRIBUTION SIMULATION SEAL STRENGTH AND INTEGRITY STABILITY TESTING STERILITY TESTING

ACCELERATED AND REAL TIME AGING STERILITY VISUAL INSPECTION PEEL TEST DYE PENETRATION BURST TEST BUBBLE TEST ATMOSPHERIC CONDITIONING COMPRESSION TEST VIBRATION TEST DROP TEST

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SLIDE 43

KINETIC STUDIES FOR DRUG ELUTING STENTS

EVALUATION OF DRUG RELEASE KINETICS PHARMACOKINETIC MONITORING

BIO AVAILABILITY ABSORPTION RATE HALF LIFE VOLUME OF DISTRIBUTION EXTRACTION RATIO HEPATIC CLEARANCE RENAL CLEARANCE AUC DISTRIBUTION ELIMINATION ELIMINATION KINETICS METABOLITE ESTIMATION ENZYMATIC CHANGES EVALUATION OF KINETIC MODELS PREDICTION OF INVITRO RELEASE ENZYME AND RECEPTOR KINETICS

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SLIDE 44
  • S. No.

NAME OF THE EQUIPMENT MAKE MODEL

1. ICP/MS/MS AGILENT TECHNOLOGIES G3271A 2. GC/MS/MS WATERS QUAPPRO 3. LC/MS/MS ABSCIEX API 6500 4. RT-PCR APPLIED BIO SYSTMES STEP ONE 5. IMMUNO CHEMISTRY ANALYZER ABBOTT AXSYM 6. 2D ELECTROPHORESIS BIORAD MINI SUB CELL GT 7. HEMATOLOGY ANALYZER (XP-100) SYSMTEX XP-100 8. BIOCHEMISTRY ANALYZER (XI-640) TRANSASIA ERBA XL-640 9. ROTARY MICROTOME LEICA RM2125RT 10. AUTOMATIC TISSUE PROCESSOR LEICA TP1020 11. PARAFFIN EMBEDDING STATION LEICA EG1150H 12. COLD PLATE LEICA EG1150C 13. ELECTRIC TISSUE FLOAT BATH LEICA TP1020 14. AUTO STAINER LEICA XL 15. STABILITY CHAMBER THERMO LAB GMP 16. FT-IR PERKIN ELMER FRONTIER 17. DSC PERKIN ELMER PYRIS 6-DSC 18. DISSOLUTION LAB INDIA DS-14000 19. UNIVERSAL TESTING MACHINE DAK SYSTMES UTB9051 20. VIBRATION TESTER SED

  • LABORATORY EQUIPMENT
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SLIDE 45
  • Toxic Residues
  • Pesticide Residue as per WHO & EPA
  • Residual Solvents
  • Heavy Metals
  • Microbiological Evaluation

FOOD & SAFETY ANALYSIS

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SIPRA LABS LIMITED

HYDERABAD, INDIA VISIT US @ www.sipralabs.com Tel: 91-40 23802000 E-mail: sipra@sipralabs.com