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SOP for Aseptic Techniques

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Standard Operating Procedure (SOP) for Aseptic Techniques

1.0 Purpose: The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for performing aseptic techniques in a laboratory environment to prevent contamination of sterile materials, media, and equipment.

2.0 Scope: This SOP applies to all laboratory personnel who are involved in the handling of sterile materials, media, and equipment.

3.0 Responsibilities: It is the responsibility of laboratory personnel to follow the guidelines outlined in this SOP to ensure that aseptic techniques are properly employed.

4.0 Procedure:

4.1 Personal Hygiene:  Laboratory personnel should wash their hands thoroughly with soap and water before entering the laboratory. Jewelry, watches, and other accessories should be removed, and long hair should be tied back to prevent contamination.

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4.2 Sterilization: All equipment and materials that come into contact with sterile materials and media must be sterilized before use. Autoclaving is the preferred method of sterilization.

4.3 Work Environment:  The work environment should be clean and free of clutter. Work surfaces should be disinfected with 70% ethanol or a similar disinfectant before and after use. The laboratory should be well-ventilated to prevent the accumulation of airborne contaminants.

4.4 Technique:  Aseptic technique is the process of handling sterile materials and media in a manner that prevents

contamination. The following guidelines should be followed when performing aseptic technique:

4.4.1 Work in a laminar flow hood or biosafety cabinet whenever possible to prevent contamination from the surrounding environment.

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4.4.2 Flame sterilize all equipment and materials that come into contact with sterile materials and media. This includes forceps, pipettes, and culture tubes.

4.4.3 Do not touch non-sterile surfaces or objects while working with sterile materials and media.

4.4.4 Use sterile gloves when handling sterile materials and media.

4.4.5 Use sterile technique when transferring sterile materials and media from one container to another. This includes the use of sterile pipettes, syringes, and needles.

4.4.6 Do not touch the inside of culture tubes or petri dishes with the pipette tip or forceps.

4.4.7 Do not breathe directly into the culture tube or petri dish when transferring materials.

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4.4.8 Recap culture tubes and petri dishes immediately after use to prevent contamination from the surrounding environment.

4.4.9 Dispose of all contaminated materials in a biohazard waste container.

4.5 Monitoring: The efficacy of aseptic techniques should be monitored regularly. This can be accomplished by performing regular environmental monitoring and testing of media for contamination.

References:  List any references used in the development of this SOP.

Revision History: List any revisions to this SOP, including the date of the revision and a brief description of the changes made.

 

Microbiology Testing

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
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  • Formulation Development
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  • Good Distribution Practice
  • Good Warehousing Practices
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  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
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  • Microbiology Testing
  • Nanoparticle Formulation
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  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
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