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Cleanroom Classification Grades Explained

The document outlines the classification of cleanrooms under GMP requirements, detailing four grades: A, B, C, and D, with Grade A being the highest standard for high-risk operations and Grade D for less critical stages. Each grade has specific criteria for air quality, particle limits, cleaning frequency, gowning strategies, and personal qualifications. The overall classification emphasizes the importance of maintaining stringent environmental controls in pharmaceutical manufacturing.

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Hicham Terry
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39 views3 pages

Cleanroom Classification Grades Explained

The document outlines the classification of cleanrooms under GMP requirements, detailing four grades: A, B, C, and D, with Grade A being the highest standard for high-risk operations and Grade D for less critical stages. Each grade has specific criteria for air quality, particle limits, cleaning frequency, gowning strategies, and personal qualifications. The overall classification emphasizes the importance of maintaining stringent environmental controls in pharmaceutical manufacturing.

Uploaded by

Hicham Terry
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

𝗖𝗹𝗲𝗮𝗻𝗿𝗼𝗼𝗺 𝗮𝗻𝗱 𝗶𝘁'𝘀 𝗰𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻- P𝗮𝗿𝘁 𝟮 (By HSD)

👉Under the GMP requirements, the manufacturing of pharmaceu cal


products can be dis nguished into 4 grades: Grade A, B, C & D.
A = excellent. B = good. C = sa sfactory. D = less than sa sfactory.

👉Examples of grades for asep c prepara on and processing opera ons.

➡𝗚𝗿𝗮𝗱𝗲 𝗔:
👉Defini on: A zone for high-risk opera ons that need the highest level of
environmental control.
👉ISO: ISO Class 5
👉Airflow: Under LAF unidirec onal
👉Air velocity: 0.36 – 0.54 m/s at working height
👉U lity: Sinks and drains prohibited in Grade A
👉Par cle monitoring frequency: Con nuous

Wri en By: Harendra Singh Dayma Page 1 of 3


𝗖𝗹𝗲𝗮𝗻𝗿𝗼𝗼𝗺 𝗮𝗻𝗱 𝗶𝘁'𝘀 𝗰𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻- P𝗮𝗿𝘁 𝟮 (By HSD)

👉Limit: Se le plate <01 CFu, Ac ve air sampler :<01CFU, Surface : <01 CFU
👉Cleaning frequency: At rest condi ons per day
👉Gowning strategy: Sterilized Primary, Secondary fully polyester gown,
goggles, gloves
👉Disinfectant: Sterile filter prior to use as per in-house DET define validity
👉Handling materials: All materials must be sterile like Ar cles, process
opera on materials
👉Personal qualifica ons: On job oriented training and Skills, Media fill
par cipa on

➡𝗚𝗿𝗮𝗱𝗲 𝗕:
👉Defini on: A zone for asep c prepara on, filling, and compounding.
👉ISO: ISO Class 5 at rest and ISO Class 7 in opera on.
👉Airflow: Minimized turbulence from cri cal points
👉Air velocity: 0.45 m/s +/- 20%
👉U lity: As per Grade A
👉Par cle monitoring frequency: Con nuous
👉Limit: Se le plate <05 CFU Ac ve air sampler<10 CFU, Surface <05 CFU
👉Cleaning frequency: At rest per day
👉Gowning strategy: As per Grade A
👉Handling materials: As per Grade A
👉Personal qualifica ons: As per Grade A

➡𝗚𝗿𝗮𝗱𝗲 𝗖:
👉Defini on: The Grade C cleanroom spaces are for performing less stringent
steps of sterile product manufacturing.
👉ISO: Grade C (at rest and in opera on) is ISO 7 and ISO 8, respec vely.
👉Airflow: Some turbulence away from cri cal points
👉Air velocity: 0.45 m/s ± 20% at filter face.
👉U lity: No sinks, closed drains and water supply permi ed
👉Par cle monitoring frequency: 15 days once
👉Limit: Se le plate <50 CFU, Ac ve air sampler <100 CFU, Surface <25CFU
👉Cleaning frequency: Once in a day
👉Gowning strategy: Low par culates, Cleaned, Steriliza on not required

Wri en By: Harendra Singh Dayma Page 2 of 3


𝗖𝗹𝗲𝗮𝗻𝗿𝗼𝗼𝗺 𝗮𝗻𝗱 𝗶𝘁'𝘀 𝗰𝗹𝗮𝘀𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻- P𝗮𝗿𝘁 𝟮 (By HSD)

👉Handling materials: Protect environment but determined by process


requirements
👉Personal qualifica ons: As per SOP

➡𝗚𝗿𝗮𝗱𝗲 𝗗:
👉Defini on: Grade D cleanrooms are designated for less cri cal stages in the
manufacturing process.
👉ISO: ISO Class 8 cleanrooms, both at rest and in opera on.
👉Airflow: NA
👉Air velocity: NA
👉U lity: Basic hygiene, all equipment permi ed
👉Par cle monitoring frequency:15 days once
👉Limit: Se le plate <100 CFU, Ac ve air sampler <200 CFU, Surface < 50 CFU
👉Cleaning frequency: NA
👉Gowning strategy: PPE, Head/foot cover
👉Handling materials: Through MAL as needed.
👉Personal qualifica ons: SOP

➡𝗖𝗼𝗻𝗰𝗹𝘂𝘀𝗶𝗼𝗻:
👉However, in general, some will define these various le er grades as follows:
A = excellent. B = good. C = sa sfactory. D = less than sa sfactory.

Wri en By: Harendra Singh Dayma Page 3 of 3

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