Performance qualification pharmaceutical equipment
DYNAMIC PASS BOX
Performance Qualification Procedure:
Air Velocity:
Hot wire anemometer or Vane type anemometer is used
with proper calibration certificates.
Start the respective DPB at least 15 minutes before
conducting test.
Ensure that all the doors of respective room are
properly closed.
Check the velocities at 6” below or away from the
filter face using anemometer record the same.
Ensure that no object is present below the anemometer
while taking the reading, except the built-in equipment.
Take each reading at least for 15 second.
Check the air velocity at each filter for at least five
Spot as per figure-1 mentioned below.
Calculate the average velocity for each filter.
Record the Data in observations Table -1
Acceptance criteria: Average velocity
should be 90 ft. /min. ± 20%.
HEPA Filter Integrity test:
The filter integrity test shall be performed by
qualified and trained person only.
Measuring and testing instrument being used shall be
calibrated with reference to NPL/NABL traceable reference standard.
Filter integrity testing shall be performed after
operational velocities have been verified and adjusted where necessary.
Poly alpha olefin (PAO) shall be used for the
generation of particles/ fumes. MSDS of the same shall be provided by the
external agency.
Position the aerosol generator such that aerosol is
produced into the upstream of the subjected HEPA filter.
Provide compressed air to the fume generator at
pressure of 1.5-2 kg/cm2.
The concentration of the aerosol challenge upstream of
the filter should be between 20 mg/m³ and 80 mg/m³.
A concentration lower than 20 mg/m³ can reduce the
sensitivity of leak detection. A concentration greater than 80 mg/m³ can give
rise to excessive filter fouling over the extended test period.
Scan the upstream concentration and set photometer
100%.
Scanning should be performed over the entire downstream
face of each filter, the perimeter of each filter, the seal between the filter
frame and the grid structure, including its joints at the distance of
approximately 3 cm from the downstream filter face or the frame structure.
The probe traverse scan rate when using 3 cm x 3 cm
square probe should not exceed 5 cm/s with a rectangular probe, the maximum
area scan rate should not exceed 15cm²/s.
While scanning, any indication of leak equal to or
greater than the limit which characterizes a designated leak should be cause
for holding the probe at the leak location. The location of the leak should be
identified by the position of the probe that sustains the maximum reading on
the photometer.
Measurement of the aerosol upstream of the filters
should be repeated at reasonable time intervals between and after scanning for
leaks, to confirm the stability of the challenge aerosol concentration.
Record the Data in Observation Table-2
Acceptance Criteria: The penetration of
the HEPA filter should not be more than rated efficiency of the filter i.e.
0.01%. (ISO 14644 & WHO TRS 961)
Particle count:
The particle count test shall be performed by qualified
and trained person only.
Measuring instrument being used shall be calibrated
with reference to NPL/NABL traceable reference standard.
Ensure that the sampling locations are evenly
distributed throughout the area of the clean room.
The volume sampled at each location shall be at least 2
liters, with a minimum sampling time at each location of 1 minute. The sampling
probe shall be positioned at working level and air flow probe shall be directed
vertically upward.
Where only one sampling location is determined, minimum
of location shall be considered.
Sampling location shall be identified as per given
table.
Acceptance Criteria: All the clean
rooms should comply as per the designed class at rest as per ISO 14644 &
WHO TRS 961
Recovery Test:
The recovery test shall be performed by qualified and
trained person only.
Measuring instrument being used shall be calibrated
with reference to NPL/NABL traceable reference standard.
Locate the particle counter in the highest particle
count location identified in particle count test.
Switch “off” DPB of the room under test and adjacent
rooms.
Start particle counter and take sample till particle
count reaches beyond the acceptance criteria.
Evaluate the hold time that subjected area will remains
with clean room class.
When the particle counts level reaches more than the
specified class limit, switch “ON” the DPB of the room and adjacent rooms
immediately. Switch on the particle counter.
Record the particle count each minute until the
cleanliness level in the room is restored to the original condition &
recorded the recovery time.
Record the Data in Observation Table-4
Acceptance Criteria: Hold time shall be
established. Recovery time should not be more than 15 minutes.
Air Flow Pattern:
The air flow pattern test shall be performed by trained
and qualified person only.
Ensure area should be in rest condition and all equipment’s
are covered before starting test.
Switch on the fogger. Wait till smoke comes out.
Place outlet of fogger near supply grill and ensure
that smoke should be sufficient for visualization.
Record the Equipment name, Equipment identification
number and differential pressure reading on measuring device (if applicable).
Record the air flow pattern and direction through video
camera, gradually move fogger outlet from supply to return air grill and record
the same.
Ensure recording should be sufficient to demonstrate
the air flow direction and pattern.
Acceptance Criteria:
Smoke should flow through these critical areas in
uniform and unidirectional pattern. If the smoke return or back flow due to
turbulence, system cannot be accepted and must be rebalanced or readjusted.
Viable Air Microbial Count (Bio burden):
The test shall be undertaken to demonstrate that the bio burden concentration is not exceeding
by using Settle plate technique and air sampling technique. The test was
undertaken only in the operational state as the main source of viable microbial
load is the personnel working in the area.
Perform the Environmental monitoring by the following
two methods:
Active Sampling (By Air Sampler Method)
Passive Sampling (By Settle Plate
Method)
Frequency for environment monitoring by Air Sampler
method is daily during performance qualification for continuously one weak.
Location for the air sampler and by settle plate method
is as per Annexure-II
Active Sampling (By Air
Sampler Method)
Prepare the pre-incubated Soybean Casein Digest Agar
plates nd label the plates for details of “Sampling location, Date, Time and
Duration of exposure, and exposed by.
Sterilize the Air sampler accessories in an autoclave
at 121oC+3 for 30 minutes and put the sterilize accessories, sterile gloves and
mask in S.S container.
Wear the Sterilize gloves and mask and Place the
autoclaved SS cone inside the Air Sampler and place the prepared plate in
position (without lid).
Place the SS feeder cone circular clamp assembly in
position. Select vertical or horizontal mounting position. At the end of the
sampling period (1000 liters/8min) close the lid of the plates.
Transfer these plates to the Microbiology Lab and
incubate plates in an inverted position at 20-25°C for 72 hours followed by 48
hours at.30-35°C
After completion of incubation period record the
observations Annexure- I.
Acceptance Criteria: By Settle Plate
Method for grade “A”, class 100 < 1 CFU/ 4hours.
Passive Sampling (By Settle Plate Method)
Prepare the pre-incubated Soybean Casein Digest Agar
plates and label the plates for details of “Sampling location, Date, Time and
Duration of exposure, and exposed by.
Wrap the labelled plates in aluminum foil and put in a
caped S.S. container with Sterilize gloves and mask.
Open the plates aseptically and expose the plates on SS
Stand for four hours.
After four hours’ exposure, cover the lid of plate
aseptically and wrap with aluminum foil and place in the SS container.
Carry the plates to Microbiology lab for incubation at
20-25 C for 72 hours followed by incubation at30-35 C for 48 hours.
After incubation, take out the plates and count the
colony forming units (CFU) with the help of colony counter.
Acceptance Criteria: By Air Sampler
Method for Grade “A”, Class 100: <1 CFU/ m3.
Acceptance Criteria:
Performance qualification shall be considered
acceptable when all the conditions specified in various sections have been met.
Any deviation from the acceptance criteria of the
specific check point shall be reported and decision should be taken for the
rejection, replacement or rectification of the equipment/component.
Re-Qualification Criteria:
The DPB System shall be subjected to Re-qualification
under following conditions: -
A. The DPB
is not performing within the pre-defined acceptance criteria.
B. If any
of the test results are not within the limits defined in the acceptance
criteria.
C. If any
critical component of DPB is replaced due to technical problem.
D. Due for
re qualification as per below defined frequency: