SOP on Motility test

SOP on Motility test

This SOP is applicable for Motility test by Hanging drop Method in Microbiology Laboratory of (Pharmaceutical Company Name).

Responsibility

Microbiologist or above of Microbiology Laboratory: Preparation of SOP.

Head – Microbiology section / Nominee: Checking of the SOP.

Accountability

Head – Quality Control / Nominee: Compliance of SOP.

Abbreviations and Definitions

SOP                             : Standard operating procedure

No.                              : Number

QC                              : Quality Control

QA                              : Quality Assurance

SP                                : Specific

Procedure

Make suspension of the microbial colony.

Apply grease or Vaseline around the depression of the hanging-drop slide.

Using the inoculating loop, aseptically transfer one drop of the culture to the center of a clean cover slip.

Invert the hanging-drop slide and center its well over the drop of culture. Press down on the edge of the cover slip so that grease makes a firm seal.

Quickly and carefully turn the slide right up so the hanging drop is suspended in the depression.

Do not let the drop fall or touch the bottom of the depression.

To examine the hanging drop, first locate its edge in the center of the microscopic field, with the low power objective (10 x) and markedly reduce the light.

You will see the edge as a bright wavy line against a gray background.

Switch to the High – dry objective (45 x) and refocus on the edge of the drop.

The bacteria within the drop will then be in approximate focus and detect them by their movement and by the contrast between them and the suspending media.

Differentiate true motility from Brownian movement carefully.

Forms and Records (Annexures)

Not applicable

Distribution

Master copy       –       Quality Assurance

Controlled copies –        Quality Assurance, Production, Quality Control, Stores, Engineering and Human Resource

History:

Date Revision Number Reason for Revision
00   NEW SOP

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About Pharmaceutical Guidanace

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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