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?

1940s Signup and view all the answers

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

Controlled airflow in a restricted area. Signup and view all the answers

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

They are a major source of infection. Signup and view all the answers

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

Classification of air cleanliness. Signup and view all the answers

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

Research on airborne samplers. Signup and view all the answers

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

To control the concentration of airborne particles Signup and view all the answers

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

Air supplied through high-efficiency filters Signup and view all the answers

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

Contamination from personnel and equipment Signup and view all the answers

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

Noise level Signup and view all the answers

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

By ensuring positive pressure within the room Signup and view all the answers

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

To dilute and remove airborne particles and bacteria Signup and view all the answers

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

Choosing materials that do not generate particles Signup and view all the answers

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

Use of Clean in Place procedures Signup and view all the answers

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

0.3 μm 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?

29 particles/m3 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?

Not defined Signup and view all the answers

Why is classification inappropriate for particles in low concentrations?

High particle losses in the system Signup and view all the answers

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

Macroparticle Signup and view all the answers

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

No production equipment is present Signup and view all the answers

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

Particle counts both during operation and at rest 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?

29,000 particles/m3 Signup and view all the answers

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

100 cfu/m3 Signup and view all the answers

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

Insulin Signup and view all the answers

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

Allows for the production of human-derived insulin Signup and view all the answers

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

1 cfu/glove Signup and view all the answers

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

Concentration Signup and view all the answers

What is a common product of bioprocessing used in vaccines?

Recombinant proteins Signup and view all the answers

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

Grade D Signup and view all the answers

How are biopharmaceuticals defined?

Complex molecules from biological sources for medical use Signup and view all the answers

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

102 particles/m³ Signup and view all the answers

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

ISO 4 Signup and view all the answers

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

35,200 particles/m³ Signup and view all the answers

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

29,300 particles/m³ 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?

ISO 6 Signup and view all the answers

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

c particles/m³ Signup and view all the answers

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

ISO 3 Signup and view all the answers

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

d particles/m³ Signup and view all the answers

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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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.