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Clean Area Classification


A clean room or buffer room is an engineering control room that is secondary. Located here (the LAFH, BSC, or CA), the engineering controls are responsible for actually performing the compounding. The clean room is an enclosed environment with one or more clean zones whose airborne particle concentrations are controlled by HEPA filters, constant air circulation, and a physical barrier to unfiltered air. As a result of a clean room, acceptable airborne particles, temperature, humidity, air pressure, and airflow patterns can be created. A clean room is classified by its quality of air and how consistently it is kept clean.

Clean rooms 

Properties

Class 100 (ISO class 5)

0.5µ or larger size existing in the given cubic foot in air and the number should be less than 100 or 100

Class 1000 (ISO 6)

0.5µ or larger size existing in the given cubic foot in air and the number should be less than 1000 or 1000

Class 10000 (ISO 7)

0.5µ or larger size existing in the given cubic foot in air and the number should be less than 10000 or 10000

Table 1

A clean room consists of the following components in addition to those already mentioned:
Air-lock entry portals
To remove the particular matter from shoes, there should be a sticky mat
UV irradiation
For incoming air, treatment systems and special filtration
Positive room air pressure prevents pollutants from entering from neighboring rooms.

In terms of standards, clean rooms are classified into many classes. Table 2 shows the equivalency of classes based on several international standards.

Class 

Measured particle size (macro meter)

Federal 209 D

ISO

0.1

0.2

0.3

0.5(a)

1.0

5.01

1

3

1000

237

102

(1)

8


10

4

10000

2370

1020

(10)

83


100

5

100000

23700

10200

(100)

832

29

1000

6

1000000

237000

102000

(1000)

8320

290

10000

7




(10000)

83200

2900

100000

8




(100000)

832000

29000

Table - 2

(a) - The particle count for this size is per ft, whereas others are per m.

GRADE

Number of particles per m not less than or equal to the maximum allowed amount


At rest (b)

In operation (b)


0.5 µm (d)

5 µm

0.5 µm (d)

5 µm

A

3500

0

3500

0

B (a)

3500

0

350000

2000

C (b)

350000

2000

3500000

20000

D (c)

3500000

20000

Not defined (c)

Not defined (d)



Table – 3


Remarks


In order to achieve air grades B, C, and D, the number of air changes should be proportional to the room size, as well as the equipment and employees present. HEPA filters of grades A, B, and C should be installed in the air system.


An unmanned state (no manual action) should be received after 15-20 minutes of "clean up."


Appropriate warning and response limits for particulate and microbiological monitoring findings should be established. If these restrictions are exceeded, a remedial action should be made in the operating processes.

Depending on the nature of the product and the production method, other factors (such as temperature, relative humidity, etc.) are necessary. These criteria have no bearing on the purification classes.

Grade 

Example of operation 

Filling of products whenever it is usually at risk.

Filling of the product. When usually at risk, there is a preparation of the product

Preparation of components and solutions for subsequent filling.



Table – 4

It is recommended to process most items in a grade D environment, with grade C environments only being used when there is a particularly dangerous situation.

Grade 

An example of how to operate

Fillings and preparations should be aseptic.

Method of preparing filtered solutions.

After washing components, how to handle them



Table – 5


After washing, the components should be handled in a category D environment. Handling the sterile beginning material should take place in a grade A setting with a grade B background. In the case of sterile filtration, the solution needs to be prepared in a grade C environment. In the absence of filtration, it needs to be prepared in a grade A environment with a grade B background. In order to handle and fill items prepared in an aseptic environment, the environment should be grade A. In an area that does not have a grade B backdrop, sterile ointments, creams, suspensions, and emulsions should be prepared in a grade A environment and not filtered afterward. Control of zone purity by particles in operation and microbiological control are necessary in an aseptic production area, and the acceptable limits are shown in table 6:

Grade 

Air sample

Settle plates

Contact plates 

Glove print. Five fingers

1

<1

<1

<1

10

5

5

5

100

50

25

-

200

100

50

-



Table – 6
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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