Sterile Products Manufacturing

What is used to determine the viable count in a manufacturing facility?

Airflow mapper
Sterility tester
Particle counter
CFU (Colony-forming unit) (correct)

What type of material is recommended for the construction of walls and floors in a manufacturing facility?

Wood and wooden
Glass and fragile
Porous and rough
Nonporous and easy to clean (correct)

What is the purpose of using glass windows in partitions in a manufacturing facility?

To improve airflow
To increase air pressure
To reduce humidity
To provide better lighting (correct)

What is the recommended material for furniture in a manufacturing facility?

Steel (D) Signup and view all the answers

Where should mechanical servicing of utility lines be provided in a manufacturing facility?

Above the ceiling or below the floor or in corridor (B) Signup and view all the answers

What is a clean area defined as in a manufacturing facility?

An isolated environment strictly controlled with respect to particles and other factors (B) Signup and view all the answers

What is the primary purpose of separating areas within the clean area during sterile product manufacturing?

To prevent contamination and ensure product sterility (B) Signup and view all the answers

What is the classification of areas based on in sterile product manufacturing?

The number of particles > 0.5 um or larger per ft3 of air (A) Signup and view all the answers

What type of operation takes place in a Grade A (Level I) area?

Aseptic filtration and product filling (A) Signup and view all the answers

What feature is characteristic of Grade A (Level I) areas?

Unidirectional airflow devices (C) Signup and view all the answers

What is the purpose of Grade B (Level II) areas?

To hold sterile containers and closures (B) Signup and view all the answers

What is the main difference between Grade A (Level I) and Grade B (Level II) areas?

The location of the areas (C) Signup and view all the answers

What is the primary focus of sterile products manufacturing?

Minimizing risks of microbiological contamination and particulate and pyrogen contamination (B) Signup and view all the answers

What is the purpose of cGMP?

To protect product SISPQ (Safety, Identity, Strength, Purity, Quality) and maintain a consistent State of Control (D) Signup and view all the answers

What is a critical aspect of aseptic processing?

Maintaining sterility during filling and packaging (A) Signup and view all the answers

What is a key requirement in sterile products manufacturing?

Strictly following established and validated methods of preparation and procedure (D) Signup and view all the answers

What is the purpose of a clean room in sterile products manufacturing?

To provide a controlled environment for aseptic processing (B) Signup and view all the answers

What is the primary focus of sterilization in sterile products manufacturing?

The drug or product itself (B) Signup and view all the answers

What is the primary purpose of Level II and Level III areas in sterile product manufacturing?

To reduce bioburden and control particle counts (D) Signup and view all the answers

What is the ISO classification of the cleanest environment?

ISO Class 1 (A) Signup and view all the answers

Where are raw materials, finished products, and final inspection and packaging typically located?

Non-classified areas (C) Signup and view all the answers

What is the primary function of the washing area in sterile product manufacturing?

To clean and prepare product containers and accessories (B) Signup and view all the answers

What is the ranking of the ISO classification system?

The lower the ISO rating, the cleaner the environment (C) Signup and view all the answers

What is a crucial factor in the success of sterile product manufacturing?

Skill and training of personnel (B) Signup and view all the answers

Why is it necessary to use airlocks for personnel and equipment in clean areas?

To reduce the risk of contamination (D) Signup and view all the answers

What is the purpose of filters in the clean area?

To purify the air (B) Signup and view all the answers

What is the classification of manufacturing operations based on sterility?

Those where the product is terminally sterilized, and those conducted aseptically (A) Signup and view all the answers

What is the purpose of a slit to agar sampler (STA)?

To detect microorganisms in the air (D) Signup and view all the answers

Why is it essential to sterilize or disinfect equipment before use?

To prevent contamination of products (B) Signup and view all the answers