Clean Room Quiz 2

Clean Room Quiz 2

Question: What is the objective of the air pressure difference test.?

Answer: The objective of the air pressure difference test is to confirm the effectiveness of the cleanroom’s air movement system in maintaining the designated pressure differential between the cleanroom and its surrounding environment.

Question: When should the air pressure difference test be conducted?

Answer: The air pressure difference test should be conducted after the cleanroom has successfully met the acceptance criteria for airflow velocity or air volume flow rate, uniformity of velocity, and any other relevant tests.

Question: How is the supply airflow velocity measured in unidirectional applications?

Answer: In unidirectional applications, the supply airflow velocity is measured with individual point readings to enable velocity measurement and determination of velocity uniformity. The average of these individual velocity point readings may then be utilized to calculate the supply airflow volume and air change rate (air changes per hour).

Question: In what situations are individual velocity point readings typically not required?

Answer: Individual velocity point readings are generally not required in non-unidirectional applications, as uniformity of velocity is often unnecessary in such cases. Instead, airflow volume readings can be directly measured and then used to calculate the air change rate (air changes per hour) for the cleanroom or clean zone.

Question: What is the objective of the airflow direction test and visualization?

A: The objective of the airflow direction test and visualization is to verify that the airflow direction within the cleanroom adheres to the designated design and performance specifications. Additionally, the test aims to assess the uniformity of velocity across the cleanroom.

Question: When can the airflow direction test be conducted?

Answer: The airflow direction test can be conducted in the at-rest state to ascertain the fundamental airflow patterns within the cleanroom. Furthermore, it can be repeated in the operational state to simulate actual operations and confirm the consistency of airflow direction and velocity.

Question: What is the purpose of the recovery test?

Answer: The purpose of the recovery test is to assess the ability of the cleanroom or clean zone to return to a predetermined level of cleanliness within a specific timeframe after being briefly exposed to an airborne particulate challenge.

Question: Why is the recovery test not recommended for unidirectional airflow systems?

Answer: The recovery test is not recommended for unidirectional airflow systems due to the potential risk of introducing residue contamination into the cleanroom or clean zone when using artificial aerosols.

Question: What is the objective of the temperature test in clean room?

Answer: The objective of the temperature test is to confirm that the air temperature levels remain within the specified control limits over the designated time period, as defined by the customer, for the area under examination.

Question: What is the purpose of the humidity test in clean room?

Answer: The purpose of the humidity test is to ensure that moisture levels, indicated by relative humidity or dew point, are maintained within the predetermined control limits over the specified time period set by the customer for the area being evaluated.

Question: What is the purpose of the installed filter system leakage tests?

Answer: The purpose of the installed filter system leakage tests is to verify the proper installation of the final high efficiency air filter system. These tests confirm the absence of bypass leakage within the air filter installation and ensure that the filters are free of defects such as small holes, damage in the filter medium, frame, seal, and leaks in the filter bank framework.

Question: How are the installed filter system leakage tests conducted?

Answer: The tests are performed by introducing an aerosol challenge upstream of the filters and scanning downstream of the filters and support frame or sampling in a downstream duct. This methodology allows for the detection of any leakage in the filter system and ensures its integrity.

Question: What is the objective of the containment leak test?

Answer: The objective of the containment leak test is to determine whether there is any infiltration of unfiltered air from outside the cleanroom or clean zone enclosure into the controlled environment through joints, seams, doorways, and pressurized ceilings.

Question: What are the purposes of the electrostatic and ion generator tests?

Answer: The electrostatic and ion generator tests serve multiple purposes:

Electrostatic testing evaluates the electrostatic voltage levels on work and product surfaces, as well as the static dissipative properties of materials such as floors and workbench tops.

Ion generator testing assesses the performance of ionizers, or ion generators, in eliminating static charges on surfaces within cleanrooms or clean zones.

Question: What is the objective of the particle deposition test?

Answer:  The objective of the particle deposition test is to verify the quantity and size of particles deposited from the air within the cleanroom onto a surface over a predetermined period of time.

Question: What is the purpose of the segregation test?

Answer: The purpose of the segregation test is to evaluate the effectiveness of separation achieved by a specific airflow system. This test involves challenging a lesser classified area with particles and determining the particle concentration in the protected area on the other side of the segregation.

Question: What information should be included in the test reports?

Answer: The test reports should include the following information:

  1. a) Name and address of the testing organization, along with the date of the test.
  2. b) Reference to the document (like-ISO 14644-3:2019).
  3. c) Clear identification of the physical location of the cleanroom or clean zone tested, including reference to adjacent areas if necessary, and specific designations for coordinates of all sampling locations.
  4. d) The specified designation criteria for the cleanroom or clean zone, including ISO classification, relevant occupancy state(s), and considered particle size(s).
  5. e) Details of the test method used, any special conditions related to the test or deviations from the test method, and identification of the test apparatus along with its current calibration certificate.
  6. f) The test result, including data reported as required in the relevant clause of Annex B, and a statement regarding compliance with the claimed designation.

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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