ENVIRONMENTAL

MONITORING IN
BIO PHARMACEUTICAL
INDUSTRY
 BRIEF HISTORY OF THE COMPANY

• SHANTHA BIOTECHNICS was started

by Dr.K.I. Varaprasad Reddy.
• This company has led to the launch
of SHANVAC-B.
• It is an rDNA Hepatitis-B vaccine.
• It is the first Indian Hepatitis-B
vaccine pre qualified by WHO-
Geneva.
• It is the India’s first recombinant
human health care product in 1997.
Products of
SHANTHA BIOTECHNICS
“Shanvac™®-B” -----r-DNA
Hepatitis B vaccine
 “Shanferon™” -----r-DNA
Interferon Alpha-2b drug.
 “Shankinase™” -----recombinant
Streptokinase
Injection.
 “Shanpoietin™” -----recombinant
Human Erythropoietin Injection.
 “Shantest™-HBsAg Elisa” ---- ELISA
“Shantetra™” -----
recombinant vaccine for Diphtheria,
Tetanus, Pertussis and Hepatitis B
vaccine

 “Shantrip™” -----Adsorbed
Diphtheria Toxoid, whole-cell
Pertussis and Tetanus Toxoid.
 “ShanTT™” ----- Adsorbed
Tetanus Toxoid vaccine.
 “Shantest™ - AFP” -----[ ELISA for
the determination of Alpha-
fetoprotein]
 ABSTRACT
• Environmental conditions to be
maintained in critical and non critical
regions of production.
• They should be monitored according
to their specifications.
• Environmental monitoring is classified
into two types.
1.Viable monitoring.,
2.Non viable particulate count
monitoring.
• Viable monitoring includes counting
of colony forming units.

• Non viable monitoring includes

particle counting
 INTRODUCTION
• PURPOSE – Environmental monitoring
is to identify microbiological and
particulate control concepts and
principles.
• They relate to the manufacture of
sterile pharmaceutical products.
• These concepts also can be applied
for non sterile product manufacture.
• The focus is environmental monitoring
as it relates to facility control and
compliance.
 ENVIRONMENTAL CONTROL PROGRAM-
SUPPORTED BY
Sound facility design and
maintenance.
Documentation systems.
Validated / qualified sanitization /
disinfection procedures.
Reliable process controls.
Good housekeeping practices.
Effective area access controls.
Effective training, certification /
qualification and evaluation programs.
Quality assurance of materials and
HVAC SYSTEM COMPONENTS
• Fan(s) to circulate the supply air(SA) and
return air(RA).
• Outside air device •
Condenser(s)
• Mixed air chamber • Pump(S)
• Filter section(s) • Water
boilers
• Heat exchanger(s) • Steam
boilers
• Auxiliary heating devices • Water
chillers
• Compressor(s) • Cooling
towers
 Aim and Scope
• To achieve aseptic conditions in the
production unit.

• To reduce air borne contamination

where air is not critical in causing
contamination.

• Using HEPA filters which filter up to

0.599.97% efficiency is to be
 Materials Required
• Air sampler
• SCDA plates
• RODAC plates
• Peptone water bottles
• Sterile garments
• Particle counter
• Thermo-hygrometer
• Isopropyl alcohol (70%)
• Mop cloth
 Methodology
 VIABLE MONITORING:
2. Active air sampling
3. Passive air sampling
4. Surface monitoring by swab method
5. Personnel monitoring by RODAC
plates
 METHODOLOGY:
ACTIVE AIR SAMPLING:
Ensure that the pre-filled plates are at the room
temperature before use.
Check the SCDA plates for contamination.
Enter the production area/filling area by following
entry/exit procedures.
Transfer the air sampler sanitized with 70% IPA and
using autoclaved sieve into the process area through
material entry.
Swipe the exterior of the plate with 70% IPA using a
mop cloth to prevent external contamination.
form.
•Keep the sterilized aspirating head ready.
•Operate the air sampler as follows.(Ref: SAS
instruction manual)
•Select the air volume to be sampled (1000L)
•Label the plates with location, date, and signature.
•Insert the plates and remove the lid.
•Place the aspirating head.
•Press START button to start the cycle.
•At the end of the cycle, remove the aspirating head.
•Close and remove the contact plate.
•Send the plates to Quality Control for
further testing along with a test request
 CLASS A CLASS B CLASS C CLASSD
(CFU/m³) (CFU/m³) (CFU/m³) (CFU/m³)
SPECIFICATIO
NS
<1 <10 <100 <200

ALERT ≥1 >10 >100 >200

LEVEL
ACTION 2 CONSECUTIVE COUNTS ALERT LEVEL
LEVEL
AT
PASSIVE AIR SAMPLING
1. Check the SCDA plates for
contamination.
2. Enter the production area/filling
area using personnel entry/exit SOP.
3. Transfer the plates to the controlled
area of the production block.
4. Swipe the exteriors of the plate with
70% IPA using a mop cloth to
prevent external contamination.
5. Place the plates in the pass box and
• Take out the SCDA plates from pass
box.

• Label the plates on the lower lid with

location number, date and signature.

• Identify the location to be monitored

as monitored in the respective grid
and start and exposing the plates from
inside at first and outside at last,
thereby avoiding air disturbances over
1. During exposing of plates, place the lid
in inverted position adjacent to the
plate. Expose the plates for 4 hours at
operational height.

3. After exposure collect plates from all

the location and transfer back through
pass box.

5. Transfer the plates to Quality Control

for further testing along with test
request form.
 CLASS A CLASS B CLASS C CLASSD
(CFU/m³) (CFU/m³) (CFU/m³) (CFU/m³)
SPECIFICAT
IONS
<1 <5 <50 <500
ALERT
≥1 >5 >50 >100
LEVEL
ACTION 2 COUNTS AT ALERT LEVEL
LEVEL CONSECUTIVE
 SURFACE MONITORING
BY SWAB TEST:
• Collect all the required material for the
monitoring program and transfer them
to the controlled area of the
production block/filling area.

• Enter the sterile area using the

personnel entry/exit SOP.
 Place all the testing material in the pass
box and switch on the UV light. Close the
door.

Identify the location to be monitored as

mentioned in the respective RST
 Remove the swab dipped in 0.1%
peptone water bottle.

 Transfer the samples to the Quality

Control laboratory along with the test
request form.
 CLASS A CLASS B CLASS C CLASS D
(CFU/m³) (CFU/m³) (CFU/m³) (CFU/m³)
SPECIFICA
TION
<1 <5 <25 <50
ALERT ≥1 >5 >25 >50
LEVEL
ACTION LEVEL 2
COUNTS ALERT LEVEL
CONSECUTIVE
AT
PERSONNEL MONITORING
BY RODAC PLATES:

Collect all the required material for

the monitoring program and transfer
them to the controlled area of the
production block/filling area.

Enter the area using entry/exit SOP.

Swipe the exteriors of the plate with 70%
IPA using a mop cloth to prevent external
contamination.

Place all the testing material in the pass box

and switch on the UV lamp.

Take the impression on the personnel after

growing with RODAC plates from fore head,
chest, left hand and right hand.

.
Label the plates with location,
name of the person, date and
shift.

Instruct the personnel who

underwent sampling to change
garments and gloves after the
procedure
 •after the procedure.

LOCATION OF SPECIFICATIO ALERT LEVEL ACTION

THE PLATE NS LEVEL

CLASS A B C A B C 2

CHEST <1 <5 <50 ≥1 >5 >20 CONSECUTIVE

FORE HEAD <1 <5 <50 ≥1 >5 >20 COUNTS AT

LEFT HAND <1 <5 ≥1 >5 >20 ALERT

RIGHT HAND <50

<1 <5 <50 ≥1 >5 >20 LEVEL
NON VIABLE
MONITORING
 PARTICLE COUNTING

• It is useful in detecting significant

deviations in gas or liquid
cleanliness.

• It is useful as a tool for qualification

and monitoring before, during and
after operations.
ENVIRONMENTAL MONITORING PROGRAM
SCHEDULE:
 

In addition to the regular schedule,

environmental monitoring shall be
carried out in the effected area after
any intervention that includes area
modification and repairs. Such records
shall be a part of the area qualification
exercise.
 VIABLE PARTICLE SCHEDULE TEMPERATURE,
COUNTING NON- PRESSURE,
AREA
RELATIVE
VIABLE HUMIDITY
PARTICLE
COUNTING
WEEKLY ONCE MONTHLY DURING EVERY
PROCESS
ONCE SHIFT
AREA

THRICE DURING THRICE DURING EVERY

FILLING EVERY FILLING DURING SHIFT
EVERY FILLING
PROCESS(BEGINNIN
AREA PROCESS(BEGIN
G,
SUMMARY:
• Environmental monitoring program is a
key element of contamination controls.
The contamination controls take a
comprehensive view of al l the potential
vector that is
• Air
• Personnel
• Surface
• Design
• Contamination control can be achieved by
design, how ever its maintenance should
be achieved on a critical basis only by
THANK YOU