Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
Scribd Logo
Upload

Welcome to Scribd!

  • 223 views

    Clean Room 1

    Uploaded by

    monoj5859
    1) Clean rooms are carefully controlled environments used in pharmaceutical production to minimize contamination. They maintain strict limits on airborne particles and control temperature, humidity, and pressure. 2) Several standards define clean room classes based on maximum permitted particles of different sizes in the air. The most common are ISO, US Federal, and EU GMP standards. 3) Proper HVAC systems, air filtration, air changes, and airflow patterns are required to maintain clean room environments. Monitoring involves biologic and particulate sampling methods to evaluate environmental conditions.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd

    Clean Room 1

    Uploaded by

    monoj5859
    223 views15 pages
    1) Clean rooms are carefully controlled environments used in pharmaceutical production to minimize contamination. They maintain strict limits on airborne particles and control temperature, humidity, and pressure. 2) Several standards define clean room classes based on maximum permitted particles of different sizes in the air. The most common are ISO, US Federal, and EU GMP standards. 3) Proper HVAC systems, air filtration, air changes, and airflow patterns are required to maintain clean room environments. Monitoring involves biologic and particulate sampling methods to evaluate environmental conditions.

    Original Description:

    Introduction

    Copyright

    © © All Rights Reserved

    Available Formats

    PPTX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    1) Clean rooms are carefully controlled environments used in pharmaceutical production to minimize contamination. They maintain strict limits on airborne particles and control temperature, humidity, and pressure. 2) Several standards define clean room classes based on maximum permitted particles of different sizes in the air. The most common are ISO, US Federal, and EU GMP standards. 3) Proper HVAC systems, air filtration, air changes, and airflow patterns are required to maintain clean room environments. Monitoring involves biologic and particulate sampling methods to evaluate environmental conditions.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    223 views15 pages

    Clean Room 1

    Uploaded by

    monoj5859
    1) Clean rooms are carefully controlled environments used in pharmaceutical production to minimize contamination. They maintain strict limits on airborne particles and control temperature, humidity, and pressure. 2) Several standards define clean room classes based on maximum permitted particles of different sizes in the air. The most common are ISO, US Federal, and EU GMP standards. 3) Proper HVAC systems, air filtration, air changes, and airflow patterns are required to maintain clean room environments. Monitoring involves biologic and particulate sampling methods to evaluate environmental conditions.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    You are on page 1of 15
    At a glance
    Powered by AI
    The key takeaways are that clean rooms aim to control airborne particle concentration and other environmental factors like temperature, humidity and pressure to minimize contamination. Clean rooms are important for pharmaceutical production where sterility is critical.

    The main clean room classifications discussed are ISO, US Federal, and British standards which classify clean rooms based on maximum allowed particle counts per cubic volume of air. Examples include ISO 1-9 and US Federal Class 1-100,000.

    Factors that are controlled in clean rooms include temperature (usually 68-74F), humidity (usually 45-55% RH), air changes (10-20/hour), air velocity (100ft/min) and use of HEPA filters to filter particulate matter.

    CLEAN ROOM TECHNOLOGY

    Clean room’s for Pharmaceutical Production

    A room in which the concentration of airborne particles


    is controlled, and which is constructed and used in a
    manner to minimize the introduction, generation, and
    retention of particles inside the room and in which other
    relevant parameters, e.g. temperature, humidity, and
    pressure, are controlled as necessary.
    Importance of Clean room
     Sterile product
     Dispensing area
     Cross Contamination
     Personal Safety
     Personal Convenience
     In the field of research
    Top ten issues to design a clean room
    1. Clarity about the GMP and standard used.
    2. Unidirectional airflow specification and qualification.
    3. Clean room pressurization.
    4. Air change rates and recovery time in non-unidirectional systems.
    5. Clean room configuration for the service and maintenance of process
    equipment.
    6. Validation of building control systems.
    7. Real time particle monitoring systems.
    8. Retest and requalification frequency.
    9. Bio decontamination by fumigation/ sterilization methods.
    10. High efficiency particulate air (HEPA) filters leak testing.
    Clean room standards

     ISO standard: ISO class 1, 2, 3 ………. 9


     US Federal standard: Class 1, 10, 100 ….. 100,000
     Class M1, M1.5, M2 …….. M7
     British standard: Class C, D, E, F, G, H, J, K, L, M.

    All the standards are based on the measurement of maximum number of particles of
    varying sizes which may be present in a specified volume of air.
     Class X clean room – means that particle count in the air is not more than X per
    cubic feet ( ft3 ) of 0.5 µm and larger in size.
     ISO X clean room - means that particle count in the air is not more than 10 X per
    cubic meter ( m3 ) of 0.1 µm and larger in size.

    Class 100 area Strict aseptic and clean room


    operations
    Class 10,000 area Buffer zone around class 100 area
    (handling pre cleaned containers, process
    filtration, gowning of personnel)

    Class 100,000 area Laboratories, packaging area.


    US FEDERAL STD 209E clean room Standards
    maximum particles / ft³
    ISO
    Class
    ≥ 0.1 µm ≥ 0.5 µm ≥ 5.0 µm equivalent

    1 35 1 ISO 3

    10 350 10 ISO 4

    100 100 ISO 5

    1,000 1,000 7 ISO 6

    10,000 10,000 70 ISO 7

    100,000 100,000 700 ISO 8


    ISO 14644-1 clean room standards
    maximum particles / m³
    FED STD 209E
    Class
    ≥ 0.1 µm ≥ 0.5 µm ≥5.0 µm equivalent

    ISO 1 10
    ISO 2 100 4
    ISO 3 1,000 35 Class 1
    ISO 4 10,000 352 Class 10
    ISO 5 100,000 3,520 29 Class 100
    ISO 6 1,000,000 35,200 293 Class 1000
    ISO 7 352,000 2,930 Class 10,000
    ISO 8 3,520,000 29,300 Class 100,000
    ISO 9 35,200,000 293,000 Room air
    European Union Guide to GMP

    maximum particles / m³
    Microbial
    Class
    ≥ 0.5 µm ≥5.0 µm growth(CFU)

    A 3500 0 ‹1

    B 350000 2000 ‹5

    C 3500000 20000 ‹50

    D Not defined ‹100


    Environmental control in clean rooms
    The environment in a sterile product manufacturing area is classified
    based on its intended use.
    Classification Clean room standard Intended use
    (US FED STD)
    Critical or 100 (Allowable particle 100, alert Sterile products, containers and closures are directly
    Level I level 50) exposed; sterile filtration, filling and sealing is performed.
    Controlled or 10,000 (Allowable particle 10,000, Area adjacent to level I area; area for storage of unexposed
    Level II alert level 7,000) sterile raw materials, products, containers etc.

    Ancillary Or 100,000 (Allowable particle 100,000, Washing and cleaning of product and accessories; product
    Level III alert level 80,000) preparation and sterilization area.
    Non classified Final inspection, labeling and packaging; warehouse for raw
    materials and finished products.
    Design of environmental contamination control system
    HVAC
    Heating, ventilation and air conditioning system is an integral part
    of environmental contamination control system.
    The purpose of HVAC system is to provide a specified set of
    environmental conditions required for the manufacturing process.

    Temperature control: 68-74F (19-23C)


    Lower temperature maybe required in some cases, such as when
    wearing poorly ventilating garments. Proper temperature setting
    reduces perspiration which, in turn, provides comfort and decreases
    chance of contamination.
    Humidity control
    RH usually maintained in the range of 45 - 55%. Some products may require 15 -
    30% RH, such as freeze dried products.

    Airborne contamination control


    Filters having required level of performances are employed to remove
    contamination. This includes the use of HEPA filters to generate a strictly aseptic
    area.
    High efficiency particulate air filter (HEPA filter)
    At least 99.97% efficient in removing particles of 0.3 µm size and larger
    HEPA filters are made of glass fibers associated with fillers or electrostatic precipitators.
    ► 10 – 20 complete air changes per hour is desirable.
    ► Air is also conditioned for temperature and humidity control.
    ► Pre filters are always used.
    ► Air velocity employed: 100 ± 2 ft. / min.
    Vertical air flow system is usually used in larger area during aseptic operation
    (air flow from ceiling to floor).

    ► Horizontal air flow system is usually employed in small work benches.


    Evaluation / Monitoring of clean room environment

    Method Principle of operation Type

    Settling plates Gravitational falling of microorganisms over agar Biologic


    plates in a given time and area
    Slit sampler Measured volume of air drawn under vacuum and Biologic
    impacted on moving agar plates
    Liquid impinger Measured volume of air bubbled through liquid Biologic
    nutrient medium with impingement in liquid
    Membrane filter Measured volume of air drawn through filter which Biologic and
    sampler is then incubated in nutrient agar plates and / or Particulate
    examined microscopically for particle count
    Light scattering Particles scatter light which is directed to photo Particulate
    instrumental counter detector tube for detection and counting.

    You might also like