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Day 1 - Introduction To Aseptic Processing

This document provides an introduction to aseptic processing. It discusses key terms like aseptic, sterility assurance level, and sterile. It outlines the objective of aseptic processing as assembling previously sterilized products in a highly controlled environment to produce a sterile unit. The document lists various aseptic processing environments and important process components, including facility design, HVAC systems, environmental monitoring, and personnel training. It emphasizes developing a strong understanding of each unit operation and how they work together as interconnected strands in the rope model of aseptic processing.

Uploaded by

Hèctor Rodriguez Salinas
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
75 views

Day 1 - Introduction To Aseptic Processing

This document provides an introduction to aseptic processing. It discusses key terms like aseptic, sterility assurance level, and sterile. It outlines the objective of aseptic processing as assembling previously sterilized products in a highly controlled environment to produce a sterile unit. The document lists various aseptic processing environments and important process components, including facility design, HVAC systems, environmental monitoring, and personnel training. It emphasizes developing a strong understanding of each unit operation and how they work together as interconnected strands in the rope model of aseptic processing.

Uploaded by

Hèctor Rodriguez Salinas
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Introduction to

Aseptic Processing

David Matsuhiro
Cleanroom Compliance Inc.
[email protected]

Aseptic Processing Training Program


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Background
Information

• Name
• Department
• Years in the Industry
• Micro Experience/Classes
• Aseptic Gown Qualified
• Media Fill Qualified
• Specific Areas of Interest
• Expectation
Aseptic Processing Training Program
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1
Introduction to
Aseptic Processing
• Aseptic
 The absence of microorganisms capable of
causing infection or contamination.
• Aseptic processing
 The method of manufacturing to produce
sterile products that are not subjected to
terminal sterilization

Aseptic Processing Training Program


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Introduction to
Aseptic Processing

• Sterile
 The absence of living organisms

• Sterility Assurance Level (SAL)


 The probability that a filled unit, after sterilization,
might contain a viable organism that survived the
sterilization process.

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Introduction to
Aseptic Processing

• Sterility Assurance Level (SAL)


 For Terminally sterilized units, the probability is 10-6
or 1 in 1,000,000
 For Aseptic Processed units, the probability is 10-3
or 1 in 1,000 in the 1980’s
 With advances in technologies and a better
understanding of the process and risk, the
contamination rate is quickly approaching 10-6 for
aseptic processing
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Introduction to
Aseptic Processing

• Objective of Aseptic Processing


 To assemble previously sterilized commodities
and products, in a highly controlled environment,
to produce a sterile unit
 Examples of these environments are
Grade - A
ISO - 5
Class - 100

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3
Introduction to
Aseptic Processing

• Aseptic Processing Environments


 Bio-Safety Cabinets
 Laminar Flow Hoods
 Traditional Clean rooms
 Clean Rooms with Curtains or Barriers
 Restricted Access Barrier Systems
 Hard or Soft Wall Isolators

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Introduction to
Aseptic Processing

• Process Components
 Facility Design & Process Flow
 Heating, Ventilation and Air Condition (HVAC)
 HEPA Filter Grid Pattern and Testing
 Room Air Exchanges
 Airflow Studies/Smoke Studies
 Fill Room Validation, IQ, OQ & PQ
 Defining Autoclave Requirements & Validation

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Introduction to
Aseptic Processing

• Process Components
 Basic Knowledge of Microbiology
 Cleaning & Sanitization
 Environmental Monitoring, Validation & Routine
 Aseptic Gowning Methods & Techniques
 Personnel Monitoring Programs
 Operator Proficiency Qualification
 Sterilization Methods and Validation

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Introduction to
Aseptic Processing

• Process Components
 Aseptic Techniques
 Contamination Control
 Lyophilization Process & Validation
 Media Fills/Aseptic Simulation
 Sterility Testing
 Change Control Systems & Requirements

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5
Introduction to
Aseptic Processing

• Process Components
 Trending
 Risk in the Aseptic Processing
 New Technologies
 Global Regulatory Requirements

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Introduction to
Aseptic Processing

• Develop an Understanding of the following


 What is pharmaceutical processing from a microbial
standpoint
 How does each unit operation work and fit into the
over aseptic scheme
 Why is each system important to the process

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Introduction to
Aseptic Processing

• Contamination Control
 Identify the weaknesses in the process
 Modify the process or procedure to compensate for
the weakness
 Validate the process
 Ensure all personnel understand the process and how
it impacts process operations

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Introduction to
Aseptic Processing

• Contamination Control
 Develop strong unit operations of the process
 Develop user friendly SOP’s to eliminate errors
process confusions
 Provide useful and meaningful training
 Develop a pro-active and not re-active approach to
pharmaceutical issues

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Introduction to
Aseptic Processing

• What are these and how/why is it associated


with processing

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Introduction to
Aseptic Processing

• Rope Model
 Each fiber is intertwined to make a thread
 The threads are woven together to make a line
 Lines are put together to form a cord
 The cords are intertwined to make a Rope
 Each individual fiber, thread, and cord are put together
to make a strong unit
 The more fibers, threads and/or cords that break, the
higher the risk of the rope failing
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8
Introduction to
Aseptic Processing

• Rope Model
 Each Unit operation of pharmaceutical microbiology is
like a strand of a rope
 Identify the basic strands of the ROPE
 Understand the HOW each strand functions
 Learn WHY each strand is important
 The more unit operations that have issues or fail, the
higher risk to the product

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Introduction to
Aseptic Processing

• The Biggest Issue Associated with Aseptic


Processing
 Lack of understanding of the overall process
 Companies have experts in the individual departments
 Most companies do not have an expert that
understands how the pieces of the puzzle fit into the
overall matrix of pharmaceutical processing

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Introduction to
Aseptic Processing

Let the Fun Begin !

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