Applied Microbiology & Cleanroom Tech Overview
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Questions and Answers

What is a key feature of the materials used in cleanroom construction?

  • They are lightweight and cheap.
  • They are insulated for sound control.
  • They produce minimal heat.
  • They do not generate particles. (correct)

Which surgical practice was introduced by Lord Lister to reduce infection rates?

  • Use of steam sterilization.
  • Gowns for medical personnel.
  • Regular hand washing.
  • Germicidal air sprays. (correct)

What significant change occurred by 1900 regarding surgical practice?

  • Mandatory use of antibiotics.
  • Reduction in operating room sizes.
  • Introduction of surgical gloves, masks, and gowns. (correct)
  • Implementation of robotic surgery.

During which period was ventilation technology for cleanrooms notably developed?

<p>1940s (A)</p> Signup and view all the answers

Which of the following contributed to a significant drop in the sepsis rate during hip replacement surgeries?

<p>Controlled airflow in a restricted area. (B)</p> Signup and view all the answers

What was one primary finding concerning people in the context of cleanroom environments during the 1960s?

<p>They are a major source of infection. (B)</p> Signup and view all the answers

What is the primary focus of ISO Standard 14644-1?

<p>Classification of air cleanliness. (D)</p> Signup and view all the answers

What was a notable advancement in cleanroom practices that emerged around World War II?

<p>Research on airborne samplers. (A)</p> Signup and view all the answers

What is the primary purpose of a cleanroom as defined by ISO standard 14644-1?

<p>To control the concentration of airborne particles (A)</p> Signup and view all the answers

Which method is integral to maintaining air quality in a cleanroom?

<p>Air supplied through high-efficiency filters (B)</p> Signup and view all the answers

What is one of the main concerns for microbial contamination in a cleanroom environment?

<p>Contamination from personnel and equipment (A)</p> Signup and view all the answers

Which of the following is NOT a relevant parameter controlled in a cleanroom?

<p>Noise level (C)</p> Signup and view all the answers

How does cleanroom technology ensure that no dirty air flows into the cleanroom?

<p>By ensuring positive pressure within the room (D)</p> Signup and view all the answers

What is the main function of high-efficiency filters in a cleanroom?

<p>To dilute and remove airborne particles and bacteria (D)</p> Signup and view all the answers

Which aspect of cleanroom design is critical for preventing particle generation?

<p>Choosing materials that do not generate particles (A)</p> Signup and view all the answers

What cleaning method specifically aims to maintain cleanrooms by utilizing controlled processes?

<p>Use of Clean in Place procedures (A)</p> Signup and view all the answers

Which particle size is used to define ISO Class 5 classification?

<p>0.3 μm (C)</p> Signup and view all the answers

In the context of GMP EU classification, what is the maximum allowed particle count for Grade B at rest for particles larger than 0.5 μm?

<p>29 particles/m3 (A)</p> Signup and view all the answers

What is the particle concentration limit for a cleanroom defined under ISO Class 5 during its in-operation state?

<p>Not defined (A)</p> Signup and view all the answers

Why is classification inappropriate for particles in low concentrations?

<p>High particle losses in the system (D)</p> Signup and view all the answers

Which particle size descriptor is adapted for specifying particle sizes in association with ISO Class 5?

<p>Macroparticle (C)</p> Signup and view all the answers

What condition distinguishes the 'As Built' classification state in cleanrooms?

<p>No production equipment is present (B)</p> Signup and view all the answers

What specific requirement is imposed by EU GMP guidelines regarding cleanroom classification?

<p>Particle counts both during operation and at rest (B)</p> Signup and view all the answers

What is the particle count for Grade C cleanrooms in the in-operation state for particles larger than 5 μm?

<p>29,000 particles/m3 (D)</p> Signup and view all the answers

What is the acceptable microbial limit for Grade C cleanroom environments regarding air samples?

<p>100 cfu/m3 (D)</p> Signup and view all the answers

Which of the following biopharmaceuticals is derived from biological sources to treat human conditions?

<p>Insulin (B)</p> Signup and view all the answers

What is the primary benefit of recombinant DNA technology in insulin production?

<p>Allows for the production of human-derived insulin (D)</p> Signup and view all the answers

In a Grade A cleanroom, what is the microbial limit for glove prints?

<p>1 cfu/glove (A)</p> Signup and view all the answers

Which step is considered the challenging part of downstream processing in bioprocessing?

<p>Concentration (B)</p> Signup and view all the answers

What is a common product of bioprocessing used in vaccines?

<p>Recombinant proteins (B)</p> Signup and view all the answers

Which of the following grades has the highest acceptable limit for settle plates?

<p>Grade D (D)</p> Signup and view all the answers

How are biopharmaceuticals defined?

<p>Complex molecules from biological sources for medical use (D)</p> Signup and view all the answers

What is the maximum particle count for ISO class 3 at a size of ≥0.3 µm?

<p>102 particles/m³ (B)</p> Signup and view all the answers

Which ISO class has a maximum of 10,000 particles/m³ for sizes ≥0.1 µm?

<p>ISO 4 (C)</p> Signup and view all the answers

How many particles per cubic meter are allowed for ISO class 6 at sizes ≥0.5 µm?

<p>35,200 particles/m³ (A)</p> Signup and view all the answers

What is the maximum count for ISO class 8 for particles of size ≥5 µm?

<p>29,300 particles/m³ (D)</p> Signup and view all the answers

In terms of ISO standards, which class corresponds to a maximum of 1,000,000 particles/m³ for sizes ≥0.1 µm?

<p>ISO 6 (C)</p> Signup and view all the answers

What is the maximum particle concentration for ISO class 7 at sizes ≥0.2 µm?

<p>c particles/m³ (A)</p> Signup and view all the answers

Which class indicates a maximum of 1,000 particles/m³ for sizes ≥0.1 µm?

<p>ISO 3 (A)</p> Signup and view all the answers

What is the maximum allowable concentration for ISO class 2 at sizes ≥5 µm?

<p>d particles/m³ (A)</p> Signup and view all the answers

Flashcards

Cleanroom

A room that controls airborne particle concentration by minimizing introduction, generation, and retention of particles, along with controlling other parameters like temperature and humidity.

Particle Control

The key goal of a cleanroom is to limit the number of airborne particles by stringent filtration and material selection.

Air Filtration

Using high-efficiency filters in a cleanroom supply system to remove particles and bacteria.

Pressure Control

Maintaining positive pressure in a cleanroom to prevent contaminated air from entering.

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Material Selection

Choosing materials in a cleanroom that do not generate particles and are easily cleanable.

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ISO 14644-1

The international standard defining cleanrooms, specifying requirements for controlling airborne particles and other parameters.

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Microbial Contamination

The presence of microorganisms in a cleanroom that compromises the sterile environment.

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Cleanroom Applications

Cleanroom technology is used for creating a controlled environment in industries requiring high sterility.

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ISO 14698

A standard for cleanroom classifications, based on particle concentration per cubic meter of air.

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FED STD 209E

A former US standard for cleanroom classifications, based on particle concentration per cubic meter of air.

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Particle Size

The size of airborne particles, often measured in micrometers (µm), which is critical for determining cleanroom class.

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Cumulative Concentration

The total number of particles of a specific size and all larger sizes allowed in a cleanroom.

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ISO 1

The cleanest class of cleanroom under ISO 14698, with the lowest allowed particle count.

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ISO 9

The least clean class of cleanroom under ISO 14698, with the highest allowed particle count.

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Cleanroom Equivalent

A way to compare different cleanroom standards, like converting FED STD 209E to ISO.

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Matching FED to ISO

The process of finding the equivalent class in ISO 14698 for a given cleanroom class in FED STD 209E.

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Lord Lister's Contribution

Lord Lister, a pioneer in surgical practices, discovered that bacteria cause surgical wound infections, leading to the use of carbolic acid as an antiseptic solution in operating rooms.

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Aseptic Techniques

Aseptic techniques evolved from Lister's methods and focus on preventing contamination during surgical procedures by sterilizing instruments, bandages, and using gloves, masks, and gowns.

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Why Cleanrooms?

Cleanrooms were introduced in hospitals to prevent airborne contamination, especially in operating theaters and other critical care areas, leading to improved patient outcomes.

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Cleanroom Standards

Standardized cleanroom design, testing, operation, and biocontamination control are crucial to maintain desired particle levels and environmental conditions.

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Ventilation in Cleanrooms

Ventilation systems play a vital role in maintaining cleanroom standards by controlling airflow and limiting particle accumulation, especially in enclosed spaces like submarines and air raid shelters.

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Airborne Samplers

Airborne samplers are tools used to study contamination dynamics, measure particle levels, and evaluate the effectiveness of cleanroom technologies.

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People as Infection Sources

People are a significant source of contamination in cleanroom environments, emphasizing the importance of strict personnel protocols and protective clothing.

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Microbial Limits

The maximum acceptable number of microorganisms allowed in a cleanroom environment. These limits are set for different grades (A, B, C, D) based on the level of contamination risk.

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Alert Limit

A threshold for microbial counts that triggers investigation but doesn't require immediate action.

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Action Limit

A critical threshold for microbial counts that requires immediate corrective action, such as cleaning or sterilization.

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Bioprocessing

Using organisms or biological molecules to produce products like pharmaceuticals or medical treatments.

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Biopharmaceutical

A medical product derived from biological sources, such as proteins, vaccines, or cell therapies, used for diagnosis, prevention, treatment, or cure.

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Recombinant DNA

DNA created by combining genetic material from different sources, used in bioprocessing to produce human-derived products like insulin.

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Upstream Processing

The initial stages of bioprocessing where cells are grown and the target molecule is produced.

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Downstream Processing

The later stages of bioprocessing where the target molecule is purified, concentrated, and prepared for use.

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ISO Class 5

A cleanroom classification with strict particle limits, requiring specialized sampling methods due to high particle concentrations.

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0.3 μm

The minimum particle size considered in ISO Class 5, meaning all particles in the count are equal to or larger than this size.

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Macroparticle Descriptor 'M'

An indicator used in conjunction with other particle sizes to specify the presence of particles larger than 1 μm in ISO Class 5 where standard classification is impractical.

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Sequential Sampling

A method used in ISO Class 5 to obtain a representative sample of particles due to the high volume of air needed for testing.

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GMP EU Classification

A classification system used by European pharmaceutical manufacturers to define cleanliness requirements for cleanrooms during different phases of operation, including 'At Rest' and 'In Operation'.

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'As Built' State

The initial state of a cleanroom after installation, with no production equipment, materials, or personnel present.

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'At Rest' State

The cleanroom state with equipment installed and operational, but no personnel present.

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'In Operation' State

The cleanroom state with personnel present and working, defined by specific agreed-upon procedures.

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Study Notes

Applied Microbiology/Pharmaceutical Microbiology and Cleanroom Technology

  • Gillian Carney, [email protected], Room 1163
  • Focuses on applied microbiology, pharmaceutical microbiology, and cleanroom technology.

Cleanroom Technology - Overview

  • Covers history and bioprocessing
  • Discusses cleanroom design and contamination
  • Explains cleaning methods
  • Examines resistance to disinfectants
  • Explores clean-in-place strategies
  • Examines monitoring techniques in cleanrooms
  • Details endotoxins and LAL assays
  • Outlines cleanroom operation

Activity

  • Students need to summarise microbial contamination and air pollution concerns in cleanroom environments and control methods.
  • Students need to identify industries where cleanroom technology is used and justify its importance in these settings.

Cleanroom Technology (What is a Cleanroom?)

  • Defined in ISO standard 14644-1.
  • A room where airborne particle concentration is controlled, minimizing introduction, generation, and retention of particles.
  • Critical parameters, e.g., temperature, humidity, and pressure, are controlled as needed.
  • Essentially, a cleanroom minimizes particle introduction, generation, and retention.
  • Air supplied is filtered with high-efficiency filters, tightly controlling parameters like temperature, humidity, etc.
  • Materials used do not generate particles and are easily cleaned.
  • Cleanroom personnel use clothing that minimizes particle and microorganism dispersal.
  • Cleanrooms also control temperature, humidity, sound, lighting, and vibration.

History of Cleanrooms (1860s-1900s)

  • 1860s-1900s (hospitals):
    • Lord Lister identified bacteria as the cause of surgical wound infections.
    • Antiseptic solutions (carbolic acid) were used.
    • 1889 Aberdeen Royal Infirmary used Lister's spray (carbolic acid) in the operating room.
    • 1890s Royal Infirmary Edinburgh introduced gowns.
    • Techniques for aseptic techniques, boiling instruments and bandages, and improved handwashing were developed.
    • By 1900, surgical gloves, masks, and gowns were introduced (steam sterilized before use).
  • 1940s:
    • Ventilation was introduced in temperate climates.
    • Major problem in crowded situations (e.g., submarines, air raid shelters).
    • Airborne samplers helped understanding contamination dynamics.
    • Most key principles of cleanroom technology developed.
    • This period highlighted the importance of people as a major source of infection.
  • 1960s-1970s:
    • Charnley & Howorth: Hip replacements, 10% sepsis rate initially, improved to <1% by 1970 with controlled air flow in restricted areas.

History of Cleanrooms (Industrial cleanrooms)

  • World War II:
    • Improved quality of weapons and vehicles.
    • Nuclear fission led to the use of HEPA filters for radioactive contaminants.
  • 1961:
    • Sandia Laboratories introduced unidirectional (Laminar flow) concept.

Modern Cleanrooms

  • Cleanroom technology is crucial for medical settings and product manufacturing.
  • Industries using cleanrooms include: semiconductor, optics, medical devices, biopharmaceuticals, pharmaceuticals, food & drink.
  • Products include integrated circuits, lenses, heart valves, insulin, vaccines, aspirin, and brewery production.
  • Cleanrooms are classified based on the cleanliness of the air (e.g., Federal Standard 209 and ISO 14644-1).

Classification and Standards

  • Cleanrooms are classified by air cleanliness, using standards like Federal Standard 209 and the ISO 14644-1 standard.
  • Airborne particle concentration, given in metric units, is logarithmic. Particles larger than 0.5 µm per m3 are considered.
  • A series of cleanroom standards including design, testing, operation, and biocontamination. Published in 1999.
  • ISO 14698 is now a key documentation for the cleanroom system.

Monitoring of Microbial Limits

  • Microbial limits are monitored.
  • Appropriate alert and action limits are set for each cleanroom environment.
  • Specifications for air samples or settle plates, contact plates, and glove prints are defined by grade (A, B, C, D).

Bioprocessing

  • Bioprocessing uses organisms and biologically derived molecules to manufacture products.
  • Biopharmaceuticals are biological medical products derived from organisms, having the purpose to diagnose, treat, prevent or cure diseases or conditions in human beings(e.g., proteins, vaccines, cell therapies).
  • Insulin production, as an example, used to involve extracting from animals; Recombinant DNA technology now allows production using microorganisms.

Bioprocessing e.g. Production of Insulin

  • Insulin, used for Type-1 diabetes (31,000 new cases per year in the EU), production methods have evolved.
  • Previously isolated from animals.
  • Recombinant DNA technology allows production of human insulin using microorganisms.

Bioprocessing Steps

  • Upstream processing, primary capture & recovery, downstream processing, final sterilization and filling and formulation.

Cleanroom Features

  • Cleanrooms have smooth unbroken surfaces and seamless, rounded joints for easy cleaning.
  • Durable, chemical resistant materials are used for cleanroom construction.
  • Airlocks and automatic doors help maintain cleanroom conditions.
  • Air circulation systems help to remove contaminants.

Occupancy States and GMP EU Classification

  • Cleanrooms are classified based upon their occupancy state (as built, at rest, in operation).
  • GMP EU classification outlines standards for particle counts in a cleanroom. Different occupancy states result in different maximum particle counts per cubic metre.

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Applied Microbiology/Pharmaceutical Microbiology and Cleanroom Technology PDF

Description

This quiz focuses on applied microbiology, pharmaceutical microbiology, and cleanroom technology. It covers the history, design, and operation of cleanrooms, including contamination control methods and monitoring techniques. Students will also explore the significance of cleanroom technology across various industries.

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