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Bioburden Control

This document discusses bioburden control in biological operations. It defines bioburden as microorganisms present on materials, products, and packages. Controlling bioburden is critical to prevent degradation, ensure safety and efficacy, and avoid affecting experimental results. Sources of bioburden include raw materials, equipment, environment, personnel, and packing materials. The document provides methods to control bioburden through various means like sourcing low bioburden materials, proper handling and storage, cleaning procedures, filtration, and aseptic techniques. The overall goal is to prevent loss of time, resources, and money.

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swapnil_ballal
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964 views

Bioburden Control

This document discusses bioburden control in biological operations. It defines bioburden as microorganisms present on materials, products, and packages. Controlling bioburden is critical to prevent degradation, ensure safety and efficacy, and avoid affecting experimental results. Sources of bioburden include raw materials, equipment, environment, personnel, and packing materials. The document provides methods to control bioburden through various means like sourcing low bioburden materials, proper handling and storage, cleaning procedures, filtration, and aseptic techniques. The overall goal is to prevent loss of time, resources, and money.

Uploaded by

swapnil_ballal
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as PPT, PDF or read online on Scribd
You are on page 1/ 15

Bioburden :The Burden

on our
Biological Operations
S.Ballal
Head, Biopharma Bulk Mfg

12/16/09 1
Objective Of This Training
 To understand
 Issues related to Bioburden
 Sources of Bioburden

 To Implement
 Methods & Systems to Control Bioburden

 Ultimate Goal
 To Prevent Loss of Time, Resources and Money

12/16/09 Confidential 2 of 15
Microbiology Primer
 Bioburden:

Population of viable microorganisms on a raw material,


component, a finished product, and/or package.

Measured in CFU (colony forming units) per unit of


product

 Sterile:
 Free from living organisms (Microbes)
 Aseptic
 Removal of Bioburden

12/16/09 Confidential 3 of 15
Where all do we need Bioburden
Control ?
 Raw Material: including water
 Resins
 Membranes
 Intermediates
 Drug Substance/Product – Stability
Samples, Control Samples
 Enzymatic reactions
 Reagents – pH standards, Buffers

12/16/09 Confidential 4 of 15
Why Bioburden Control is
Critical
 Product Degradation /Spoilage
 Safety
 Efficacy
 Appearance
 Material Degradation & Life Cycle
Reduction
 Affect experimental data & Results

12/16/09 Confidential 5 of 15
Solution for Bioburden
Control

Use everything sterile

Commercially and Technically not feasible


and not required too.

12/16/09 Confidential 6 of 15
Sources of Bioburden
 Raw Material
 Processing Equipment
 Environment
 Personnel
 Packing Material

12/16/09 Confidential 7 of 15
Bioburden Control in R
& D Set up

12/16/09 8
Material Sourcing
 Low Bioburden Products- Expensive
 Material inherently low in bioburden
 Organic Products
 Inorganic salts
 Material inherently high in bioburden
 Aqueous liquids- with / without salts & sugars
 Natural Products – Yeast Extract, Peptone

 Water- Fresh Every Day

12/16/09 Confidential 9 of 15
Raw Material Handling
 Minimize opening and
 Use clean tools for dispensing
 Keep the lid on–reduce moisture ingress
 Refrigerate when instructed/possible
 Avoid low and high bioburden processing together
 Open Critical Material in Controlled air – LFH,
Biosafety hood etc.

12/16/09 Confidential 10 of 15
Process Equipment
 Immediately clean after use
 Use bioburden reduction agents where ever possible –
NaOH, Acids, Hyprochloride
 Use Autoclaved glassware for critical operations
 If in doubt, clean/ sanitize again
 Store either in very dry state or with biostatic liquid- no
not store wet/ moist
 Periodically clean equipment thoroughly for removing soil/
grime from hard to clean areas

12/16/09 Confidential 11 of 15
Environment & Personnel
 Keep Lab area clean
 Use LFH for all critical sample handing- Stability, DS,
PCT DS / DP
 Aliquot when possible to reduce risk
 Following good handing procedures
 Sanitize hands before critical material handling
 Hold containers away from mouth/ brim
 Keep your body and other things away from the
product

12/16/09 Confidential 12 of 15
Controlling Bioburden in
Process
 Filter Buffers and solutions
 Filter Intermediates- for storage
 Filter intermediates before loading on to the
columns
 Filter all critical DS/ DP
 Avoid multiple opening and handling
 Tubing are good source of bioburden – Wet,
difficult to clean
 Use Secondary Packing – Additional Shield

12/16/09 Confidential 13 of 15
Packing Material
 Use Autoclaved Glassware and handling tools

 Always use sterile tips and pipettes

 Falcon tubes are sterile as long as you handle


them that way

12/16/09 Confidential 14 of 15
When In Doubt –

Use to Stringent
Method for Handling
12/16/09 15

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