DOVER BROOK ASSOCIATES

TECHNICAL SERVICE QUALIFICATION PROTOCOL

DBA QP-5A

Title:
Equipment Commissioning Test.
Test Objective:
To verify that the AS6 filler has been properly installed, is operating to meet all scheduled
processes, and produces a hermetically sealed pouch.
Materials/Equipment:
1) Product (1800-2000 gallons per run for three separate runs of 3000 pouches
each).
2) Incubators or warehouse storage at ambient (20C) temperatures.
3) Hydrogen peroxide diluted to 30-31%
4) Nomogram, thermometer in centigrade, hydrometer for 1.000-1.200 specific
gravity liquids.
5) pH meter
6) Buffer solutions, pH 4.0 and 7.0
7) Standard Methods or Plate Count Agar
8) Bunsen burner
9) Petri dishes (100x15mm)
10) Sterile disposable inoculating loops
11) Conductivity meter
12) 1% NaCl solution (10grams/liter DW)
13) Production film
14) Dye
Method:
Testing performed using Attachment 1 Procedure for Equipment Commissioning Test.
Acceptance Criteria:
1. Test performed in accordance with Attachment 1.
2. Actual operating conditions recorded.
3. A total of 3 separate runs will be performed in which the equipment is cleaned and sterilized prior to the beginning of each run and a total of 3000 pouches collected for each
run.
4. At the conclusion of the incubation period, a 100% inspection of the product shows no
more than five failures without assignable defects from the runs and no more than 2 failures for each individual run.
5. All documents are collected and include, charts from filler, processor and manual
recordings made by the operators.

DBA QP-5A

DOVER BROOK ASSOCIATES

Procedure for Equipment Commissioning Test

Attachment 1 :

Testing Procedures.

1. The day of the test, clean and sterilize the processor and filler. Note the test date on
the chart recorders and keep the records. Record sterilization cycle data on Attachment 2.
2. Hydrogen peroxide concentration in film tank must be 30-31% as measured using the
hydrometer and nomogram. Record peroxide concentration on Attachment 2.
3. After the filler and processor are sterile, start filling the pouches with product. Collect
five pouches to verify the size and weight. Each of the five pouches will be measured
with ruler and weighed on a scale to verify the appropriate measurements. If the five
pouches are not in the specified range of measurements adjustments will be made by the
operator. After size and weight are correct pull 10 pouches per head and test with conductivity meter. If a pouch is positive follow up with a dye test. If the dye test is positive
determine the cause of the failure and correct. Test an additional 10 pouches. Record
conductivity/dye results on Attachment 3.
4. After the container integrity has been verified, collect 3000 pouches. Collect 1500
pouches from each head to make up the 3000 needed. Mark the test number on each
container and pack in cases or other storage container. After all pouches have been collected, shut down the equipment, clean and resterilize.
5. Repeat #1-4 for a total of 3 runs.
6. After all tests are completed, store pouches in an area specifically marked for the
pouches for 10 days at ambient temperature. At the conclusion of the incubation period
perform a 100% visual inspection of all containers. If opaque film is used, all pouches will
have to be opened and the product pH determined as an indication of spoilage. Randomly
select and subculture 10% of the pouches onto SMA. Collect 30 containers for initial pH
determination. Evaluate pH and record on Attachment 4.
7. Incubate the SMA plates at 35C2 for 48 hours and observe the plates for microbial
growth.
8. The results of the pouch inspection are recorded on Attachments 5 & 6.

Attachment 6:

Commissioning Results - Summary Data.

DBA QP-5A
Page

MACHINE:
DATE:
RUN #:
POUCH SIZE:
PRODUCT:

1.

LOCATION:
% H2O2:
a) Sp. Gravity
b) Temp. (C)

Production Parameters:
Filler Sterilized:
Processor Sterilized:
Pouch QC:

Yes
Yes

No
No

Conductivity(Total #):
Passed
Dye Test(Total # Passed):
Seal Tear Down
Horizontal Seals(# Tested):
Comments:

Vertical Seals(#Tested):
Comments:

2.

Incubation:

Inspection Date:

# Pouches to Incubation:
# Pouches Passed:
Comments:

Recorded by: ______________________

Reviewed by: ______________________

Date: _________________
Date: _________________

of

DBA QP-5A

Conductivity Tests Results - Commissioning.

Attachment 3:

Page

of

Pouch Conductivity Test Results

Test Date:
Filler(Name/model):
Cont.
#

Cond.

Run #:

Dye

Recorded By: ________________

Reviewed By: ________________

Material:
Product:

Cont.
#

Cond.

Company:
Dye

Date: _____________
Date: _____________

Cont.
#

Cond.

Dye

Attachment 4:

DBA QP-5A

Tests Results - Commissioning.

Page

Initial pH Results - Commissioning.

Test Date:
Filler(Name/model):
Cont.
#

Run #:

pH

Product:
Cont.
#

Incubation Temp.(F)
Company:

pH

Product pH Range:
Mean:
SD:
3 SD:
Upper Range:

(Mean + 3SD + .15)

Lower Range:

(Mean - 3SD - .15)

Recorded By: _________________

Reviewed By: _________________

Date: ________________
Date: ________________

Cont.
#

pH

of

DBA QP-5A

Tests Results - Commissioning.

Attachment 5:

Page

of

Pouch Inspection Results - Commissioning.

Test Date:
Filler(Name/model):
Cont.
#

pH

Run #:

Growth

Recorded By: _________________

Reviewed By: _________________

Incubation Temp.(F)
Read Date:

Cont.
#

pH

Growth

Date: ________________
Date: ________________

Cont.
#

pH

Growth

Attachment 2:

Verification of Filler Sterilization.

DBA QP-5A

Machine Sterilization Cycle

MACHINE:
DATE:
RUN:

1.

TEMPERATURES:
(C)

EVENT

LOCATION:
% H2O2:
a) Sp. Gravity:
b) Temp. (C):

INCINERATED AIR:
STERILE AIR:
FILL SYSTEM:
START

STOP

PreWarm
Fill System
Misting Time
Steaming Time
Sterile Chamber
Air Piping Misting
Steaming Time
Chamber Drying
Cool Down

2. H2O2 CONSUMPTION:

mL Fill System
mL Chamber

3. Comments:

Recorded by:

Date:

Calculated by:

Date:

Reviewed by:

Date:

TOTAL(Minutes)