SOP on Maintenance and usage of Reference cultures

SOP on Maintenance and usage of Reference cultures

Objective:

  • SOP on Maintenance and usage of Reference cultures.

Responsibility:

  • Officer or above of Microbiology Laboratory:

Accountability:

  • Head – Microbiology section.
  • Head – Quality control.

Procedure

Procurement of Lyophilized Cultures

  • Reference Cultures can be procured from following suppliers:
  • ATCC: American Type Culture Collection, 10801, University Bivd, Manassas, VA201110,USA.
  • NCIM:    National Collection of Industrial Microorganism, National Chemical Laboratory, Pune 411008 INDIA.
  • MTCC: IMTECH (Institute of Microbial Technology) Sector 39-A, Chandigarh INDIA.
  • NCTC :  National Collection of Type Culture, Central Public Health Laboratory,61 Colindale Avenue, London NW9 5HT UK.

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cultures

Opening of Lyophilized ampoule:

  • Disinfect the outside of the ampoule with 70% I.P.A
  • Score the ampoule briskly with a sharp file about one inch from the top.
  • Disinfect the ampoule at the scored area with 70% I.P.A and flame.
  •  Wrap a sterile gauge pad around the scored area and break the ampoule (using the thumb and forefinger) with a sharp snapping motion away from the body.
  • Flame the open end of the ampoule and proceed as below.

 Reconstitution and maintenance procedure for Lyophilized Culture

  •  Aerobic bacteria:
  •  To the Lyophilized culture aseptically add 0.3-0.4ml of sterile Soya bean Casein Digest Medium (SCDM) with sterile pipette.
  •  Transfer the reconstituted culture to the tube containing 5ml SCDM.
  •  Transfer this culture to 7 sterile  Soya bean Casein Digest Agar (SCDA) medium slants.This is transfer no. 1(T1) from the mother culture.
  • Incubate the slants at 32.5±2.5 ºC for 24-48 hours.
  •  Simultaneously perform the purity check for this initial culture by mini API using the procedure given pack insert for specific type of organism.
  • Among the 7 slants 6 slants will serve as T1- Primary stock culture and 1 slant will serve as stand by for emergency.
  • Assign individual identification number to all 7, as T1SCA, T1SCB, T1SCC, T1SCD, T1SCE, T1SCF, and T1SCG. Give the expiry date as 1 year from the date of availability of these slants.
  •  Transfer the culture from T1SCA to  2 sterile Soya bean Casein Digest Agar (SCDA) medium Slants.
  •  Incubate the slants at 32.5±2.5 ºC for 24-48 hours.
  •  One of the 2 Slants will serve as T2 (Transfer No.1) Stock Culture (T2SCA) and other will serve as T2WCA.
  •  Give the expiry date as 15 days from the date of availability of these slants.
  •  Use the working culture slant for culture suspension preparation for routine use.
  •  Use the stock culture slant for next transfer after 15 days.
  •  Label the culture slant with following details.

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About Abha Maurya

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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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