Is Fungal Count Acceptable in Pharmaceutical Classified Area?

Know about the fungus limits in the controlled environment (classified area) in pharmaceutical manufacturing.

The Classified area is monitored for viable and non-viable particles in pharmaceutical manufacturing. Fungus and bacteria both are found in the environment. Both are determined by the air sampling using the growth medium by settle plate and active air sampling methods.

There are various regulatory guidelines for the microbial sampling of air. All have their own limits for the microbial contamination in air but none of them have a separate limit for the fungus. A general limit of the colony forming unit (cfu) is given in all guidelines.

It is important to follow these limits but it is not necessary to define an in-house limit for the fungus. Soybean casein digest agar (SCDA) or R2A plates are exposed or used in air sampler and incubated for five days. Colonies are count as cfu per plate or per cubic meter.

Following are some guidelines by different regulatory agencies showing the limit of the air sampling of the controlled area as cfu. Limits in cfu show that fungal colonies are acceptable in the classified area.

Colony Forming Unit (cfu) in Controlled Environment according to USP.

Class

 

cfu per cubic meter of air

 

cfu per cubic feet of air

SI

U.S. Customary

M3.5

100

Less than 3

Less than 0.1

M5.5

10,000

Less than 20

Less than 0.5

M6.5

1,00,000

Less than 100

Less than 2.5

Colony Forming Unit (cfu) in Controlled Environment according to WHO.


Grade

Air Sample (cfu/m3)

Settle Plates (diameter 90 mm) (cfu/4 hours)

Contact Plates (diameter 55 mm) (cfu/plate)

Glove Print (5 fingers)

(cfu/glove)

       A

< 1

< 1

< 1

< 1

       B

10

             5

               5

                       5

       C

100

50

25

                       -

       D

200

100

50

                       -

Colony Forming Unit (cfu) in Controlled Environment according to Schedule M.

 

Grade

Air Sample (cfu/m3)

Settle Plates

(diameter 90 mm) (cfu/2 hours)

Contact Plates

(diameter 55 mm) (cfu/plate)

Glove Print (5fingers)

(cfu/glove)

       A

< 1

                < 1

             < 1

           < 1

       B

10

                  5

                5

              5

       C

100

                 50

               25

               -

       D

500

                100

              50

               -
This shows that these guidelines do not say to count colonies separately as bacteria and fungus.