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SOP for Operation and Calibration of Total Organic Carbon (TOC)

  • 1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Operation and Calibration of Total Organic Carbon (TOC) Analyzer.
  • 2.0 SCOPE:This procedure shall apply for Operation and Calibration of Total Organic Carbon (TOC) Analyzer..

    3.0 RESPONSIBILITY:

    • All concerned personnel shall responsible to follow the procedure mention in this SOP.
    • Concerned Department Heads shall be responsible for compliance of the procedure.

    4.0 ACCOUNTABILITY:

    QC and QA Head shall be accountable that this SOP is implemented as per laid down procedure.

    5.0 ATTACHMENTS:

    Flow chart of Total Organic Carbon (TOC) Investigation & failure result – Attachment – I

    Format for Calibration Recording of Total Organic Carbon (TOC) – Attachment – II

    Checklist for TOC sample failure in the analysis – Attachment – III

    6.0 PROCEDURE:

    General Principle of Total Organic Carbon (TOC) Analyzer

  • TOC Analyzer converts the carbon in the sample to CO2.
  • The NDIR uses electromagnetic radiation or infrared energy to measure this CO2.
  • This measurement is proportional to the carbon in the sample.
  • Carbon dioxide shows a unique adsorption spectrum when IR energy passes through it.

Precautions during analysis of Total Organic Carbon (TOC):

  • For better analysis results, change rinsing water daily and store prepared reagents away from direct sunlight.
  • Use the sucrose and 1,4 Benzoquinone USP reference standard and store the same as per recommend storage condition.
  • Use A-grade glassware for sample collection.
  • In any case don’t rinse the glassware used for Total Organic Carbon (TOC) analysis with any solvent.
  • Glassware required for Total Organic Carbon (TOC) analysis should be cleaned for organic residue, rising with 2N nitric acid then with purified water 3-4 times and dry the TOC sampling container’s for 105°C for 30 min.
  • Preferably such glassware should be maintained separately and to be dedicated for Total Organic Carbon (TOC) analysis
  • At the sample, collection point rinses glassware with sample water 3-4 times
  • The sample should be analyzed immediately after it is received.

7.0 REFERENCES:

ISO 2859-1:1999

8.0 ABBREVIATIONS:

SOP: Standard Operation Procedure

ASI:   Automatic Sample injector

  • NPOC: Nonpurgeable organic carbon
  • TOC: Total Organic Carbon
  • 9.0 DISTRIBBUTION LIST:

    Quality Assurance

    Human Resource and administration

    Quality Control

     

    10.0 HISTORY OF REVISION:

    Version No. Effective Date Reason for revision

    for Operation and Calibration of Total Organic Carbon (TOC) Analyzer.

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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