key points of Steril Aea(continued)

Micro testing

Envoi mental monitoring report

Class A (Critical Area) limit = less than 1 cfu
Class B (Less Critical Area) limit = less than 5 cfu
Class C (Non Critical area) limit = less than 25 cfu
Class D limit = less than 100 cfu

Exposure time = 4 Hours
Incubation temperature= 30-35 co
Incubation period= 48 hours
Note= Mold or yeast absent
Frequency

RECOMMENDED LIMITS FOR MICORBIAL CONTAMINATIONS
Grade Air sample
Cfu/m3 Settle plates
( diameter 90mm)
Cfu/4 hours Contact plates
( diameter 55 mm)
Cfu/ plate Glove print ( 5 fingers)
Cfu
A <1 <1 <1 <1
B 10 5 5 5
C 100 50 25 -
D 200 100 50 -


Cloth DAB test :
Class C (Non- critical area) limit = less than 20 cfu
Incubation temperature= 30-35 co
Incubation period= 48 hours
Description
Shirt
Slave right
Slave left
Dangree upper
Frequency

Finger DAB test:
Limit =less than less than 5 cfu
Impression
Right thumb
Right index finger
Right middle finger
Right ring finger
Right small finger
Frequency

Basic environment standard for the manufacturing of sterile products

At rest In operation
Grade Maximum permitted no of particles/ m3 equal or above ( 3)
0.5 micron/f 3 Grade 0.5 micron 5 micron 0.5 micron 5 micron
A 100 A 3500 1 (6) 3500 1 (6)
B 100 B 3500 1 (6) 350,000 2000
C 10000 C 350,000 2000 3500 000 20000
D 100000 D 3500 000 20000 Not defined Not defined


LFH Air Velocity:
Unidirectional laminar airflow systems provide a homogenous air at the working position.
• Area of laminar flow hood is distributed into the nine equal parts.
• Check air velocity with anemometer or turbo meter.
• If obtained average air velocity of LFH is out of the limit, then adjust air velocity of LFH or change its HEPA filters.
Limits = 90 ± 20% Feet/min or 0.45m/s ± 20%.
• Check air velocity after every 6 months & keep its record.

Air Changes of Sterile Area: to reduce the chances of contamination circulation of fresh air is done,
In order to attain air grade B,C and D the number of air changes will be releated to the size of the area and to the equipment and personal present in the area.


• Check the speed of the filtered air entering the sterile room from inlet ducts, using anemometer, velometer or turbo-meter.
• Calculate average speed of air, filtration area of duct HEPA filter and volume of room.
• Than calculate air changes using given formula:

Air Changes = Average Air Velocity x Filtration area of HEPA filter x 60/ volume of the room.

Limit = Air Changes should not be less than 20/hours or 40/hours (in some books).