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WorksheetsSTERILE PHARMACEUTICALS CLEANROOM
Total questions: 30
Worksheet time: 16mins
Manual for Sterile Preparations prepared by Malaysian Pharmaceutical Services Programme is aligned to the guidelines by
European Medicine Agency (EMA)
Pharmaceutical Association of Malaysia (PhAMA)
British Pharmacopoeia (BP)
World Health Organization (WHO)
The most commonly used classification standard for clean rooms is
ISO 9001
FDA CFR 21
WHO TRS 961
ISO 14644-1
Clean rooms are classified based on the
size of the production facility.
number of airborne particles of a specific size per cubic meter of air.
number of employees working inside.
level of humidity.
The following statement is TRUE regarding cleanrooms classifications:
ISO Class 9 cleanroom is the cleanest.
WHO classify cleanrooms as Grade A, B, C, D, E, and F.
In hospitals, sterile products are typically prepared in a cleanroom that meets conditions equivalent to ISO Class 2.
According to the WHO classification, Grade A cleanroom is the cleanest.
The following is a primary function of a cleanroom in sterile product preparation EXCEPT:
To prevent internally generated contamination.
To maintain product sterility.
To prevent externally introduced contamination.
To keep critical areas free of contamination.
The following type of airflow system is used in clean rooms to maintain cleanliness levels:
Recirculating turbulent flow
Diffused ventilation
Laminar airflow
Reverse airflow
Materials for a cleanroom floor should have the following characteristics EXCEPT:
Non-porous surface
Rough surface
Resistant to chemicals
Anti-static properties
The following is TRUE regarding the design of a cleanroom:
Ceiling lights are flush mounted to prevent particle accumulation.
Furniture made of wood can be used.
The room have a negative pressure.
A sink is permissible in a cleanroom.
The primary role of High-Efficiency Particulate Air (HEPA) filters in clean rooms is to
cool the environment.
maintain room pressure.
reduce noise levels.
remove 99.97% of airborne particles 0.3 microns or larger.
The following statement is FALSE regarding laminar airflow hood:
It protects the products from contamination.
It can have a vertical or horizontal air flow.
Vertical laminar flow hood is commonly used in conjunction with a biosafety cabinet when handling hazardous substances.
It produces multi-directional airflow within the workspace.
The following USP general chapter emphasizes the handling of hazardous drugs:
797
799
800
997
Handling of hazardous or infectious materials should be done in a
horizontal laminar airflow hood.
vertical laminar airflow hood.
fume hood.
biosafety cabinet.
The following is the reason removal of PPE (doffing) is done in a reverse order of donning:
To make the removal process faster.
To prevent transfer of contaminants to exposed skin.
To maintain product sterility.
To demonstrate personnel competency.
The first PPE to be removed when exiting clean room is/are the
face mask.
gloves.
shoe covers.
hair cover.
The primary objective of Good Manufacturing Practice (GMP) is
to increase the profit margin of pharmaceutical companies.
to ensure that products are consistently produced and controlled according to quality standards.
to reduce the time required for product development.
to minimize production costs.
The following is a key principle of GMP EXCEPT:
Personnel should be trained and qualified.
Manufacturing areas should be clean and hygienic.
Products can be released without quality control testing if the process was validated.
Equipment should be maintained and calibrated regularly.
The following is a key element of GMP EXCEPT:
Validated process
Personnel training
Marketing strategy
Proper documentation
The following statement is FALSE regarding Quality Assurance (QA) System:
It focuses in ensuring that processes are followed consistently to produce high-quality products.
Quality Control (QC) is a component of QA.
It focuses on the testing, inspection, and analysis to detect any defects and ensuring the final product conforms to the required specifications.
Production and control of operations are clearly specified and implemented.
The significance of validation in GMP is to
ensure that equipment and processes produce consistent, high-quality products.
reduce the need for quality control testing.
allow faster production cycles.
eliminate the requirement for cleaning procedures.
The role of Quality Control (QC) in GMP is to
oversee product marketing.
monitor compliance with distribution regulations.
ensure that products meet specified quality standards.
determine product pricing strategies.
The following is a key requirement for GMP-compliant personnel:
Wearing street clothes in cleanrooms.
Undergoing regular GMP training.
Having unrestricted access to all areas.
Using mobile phones during manufacturing.
If a deviation from a standard operating procedure (SOP) occurs during manufacturing,
ignore the deviation and continue production.
discard the entire batch immediately.
document the deviation and perform an investigation.
report it to customers directly.
The following is a critical environmental condition monitored in GMP manufacturing.
Internet connectivity
Employee morale
Office lighting
Temperature and humidity
The following document is a component of GMP EXCEPT:
Batch manufacturing record
Personnel training record
Utility bills
Starting material specifications
The following is a key element in aseptic dispensing EXCEPT:
Sterile environment
Personnel hygiene
Sterile material
Dispensing counter
Aseptic dispensing
helps reduce the risk of post procedure infections in patient.
does not require the use of sterile instruments.
is not designed to protect the personnel.
is conducted in normal room environment.
The following is a precaution steps to be taken before working in a clean room EXCEPT:
Shower before coming to work in a clean room.
Ensure personal items worn, such as wristwatch, is clean.
Wear cleanroom-compatible attire.
Keep fingernails short.
The following is the correct sequence of handwashing:
Wrists - thumbs - back of hands - back of fingers - palm - fingertips - between fingers
Back of hands - palm -wrists - back of fingers - thumbs - between fingers - wrists - fingertips
Palm - thumbs - back of hands - fingertips - between fingers - back of fingers - wrists
Palm - back of hands - between fingers - back of fingers - thumbs - fingertips - wrists
The following PPE is used to prevent droplets and aerosols being inhaled:
Gloves
Face mask
Apron
Hair cover
This part of a syringe should not be touched:
Barrel
Scale
Flange
Plunger
