To lay down the procedure for spore staining.
This SOP is applicable for spore staining in Microbiology Laboratory of (Pharmaceutical Company Name).
- Microbiologist or above Microbiology laboratory: Preparation of the SOP.
- Head – Microbiology section/ Nominee: Checking of the SOP.
- Head – Quality Control/ Nominee: Compliance of SOPs.
- Abbreviations and Definitions
SOP : Standard operating procedure
No. : Number
QC : Quality Control
QA : Quality Assurance
- Prepare smear of the isolated pure culture.
- Dry the smear in air and fix with heat.
- Place the slide on a small beaker, containing boiling water, kept on the hot plate.
- Cover the smear with a small piece of filter paper; keep the filter paper saturated with a 5% aqueous solution of malachite green for about 30 minutes.
- Wash the slide gently with water.
- Counter stain with safranin for 30 seconds.
- Wash the slide with water and blot dry with whattman filter paper.
- Observe the slide under microscope 100x using immersion oil.
- The spores are stained green whereas the vegetative cells are stained pink.
- Observe the location of spore with in the cell. (E.g. Central spore, sub terminal spore, terminal spore with swollen sporangium.)
- Forms and Records (Annexures)
- Not applicable
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance, Production, Quality Control, Stores, Engineering and Human Resource
Reason for Revision
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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