Business Use

PROTOCOL FOR CHECKING THE PHOTOSTABILITY OF NEUROBION FORTE RF

INJECTION UNDER THE INFLUENCE OF SODIUM VAPOR LAMPS

PROTOCOL FOR CHECKING THE PHOTOSTABILITY

OF

NEUROBION FORTE RF INJECTION

UNDER THE INFLUENCE OF SODIUM VAPOR LAMPS

DEPARTMENT NAME: INJECTABLE

TYPE OF ACTIVITY: PHOTOSTABILITY TESTING

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PROTOCOL FOR CHECKING THE PHOTOSTABILITY OF NEUROBION FORTE RF

INJECTION UNDER THE INFLUENCE OF SODIUM VAPOR LAMPS

Table of Content

Title.

1. Purpose

2. Scope

3. Responsibility

4. Procedure

5. Acceptance criteria

6. Frequency

7. Supporting documents
 Business Use

PROTOCOL FOR CHECKING THE PHOTOSTABILITY OF NEUROBION FORTE RF

INJECTION UNDER THE INFLUENCE OF SODIUM VAPOR LAMPS

1. PURPOSE

The aim of this validation is to provide the documented evidence for the following

 The intrinsic photostability characteristics of Neurobion forte RF should be evaluated to

demonstrate that, as appropriate, light exposure does not result in unacceptable change.
 Photostability testing is carried out on a single batch of
Under
some circumstances these studies should be repeated if certain variations and changes are
made to the product (e.g., formulation, packaging). Whether these studies should be
repeated depends on the photostability characteristics determined at the time of initial
filing and the type of variation and/or change made.
2. SCOPE

Microbial count of production equipments after initial cleaning and after 6 days of storage in
equipment storage area.

Microbial count of used Production equipments after use and after 3 days of holding in
equipment washing area.

Equipments taken up for the study shall include S.S. Containers, S.S. scoops, Drying pan,
FRP trays, PVC crates, Gel holding tank, Dusters used for capsule drying, Net chopping m/c,
centrifuge, gelatine reactor, Vitamin E blending reactor, paste plant, Vitamin E Blend holding
tanks, Encapulation m/c change parts and medicament silicon tubing.

3. RESPONSIBILITY FOR THE STUDY

3.1 Quality Assurance:

- Prepare Validation Protocol.

- Overall adherence to the protocol.
- Monitoring protocol correctness & accuracy.
- Sampling of the swab samples.
- Generation of report.

3.2 Quality Control

- Testing of the samples.

- Tabulation of the data

3.3 Production:
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PROTOCOL FOR CHECKING THE PHOTOSTABILITY OF NEUROBION FORTE RF

INJECTION UNDER THE INFLUENCE OF SODIUM VAPOR LAMPS

- To wash, dry and store the equipments as per Standard operating procedure.
- To store the used equipment in washing area with status label.
- To provide support during sampling of the equipments.

3.4 Manager Pharma Production and Manager Quality Assurance:

- To authorise the critical acceptance criteria for the tests being performed.
- To review & approve the test results.

4. PROCEDURE

4.1 Procedure for uncleaned equipments:

One representative equipment from similar group of equipments shall be taken for the study,
for e.g. from a group of 5 similar type of S.S. Containers, only one shall be taken for the
study.

The equipments selected for the hold time study shall be kept in the equipment washing area
after usage. The storage condition should be similar to that routinely followed.
While sampling wear gloves which are disinfected, clean over gown, head gear and nose
mask.
Swab sampling technique shall be uses as the used equipments will be oily and rinse
sampling will not result in effective sampling.

Ready made sterile swabs supplied by Hi Media shall be used. Test tube for collecting the
swabs should be sterilized in QC Microbiology section. The sterilised test tubes should be
covered with two layers of butter paper before taking it to Softgel department. Remove one
layer of butter paper in Production airlock and last one in production office before taking the
test tube for sample collection.

After the used equipments have been transferred to washing area collect two swabs from two
different locations per equipment. After sampling place the swabs in a sterile test tube.
Swabs of each sampled equipment are to be collected in separate sterilised test tube and the
test tube shall be labelled with the equipment name.
Approximately 20mm X 20mm area is to be sampled per swab. In case of smaller equipment
like scoops, sample maximum possible surface area.

These equipments after sampling shall be labelled with the status label as “UNDER HOLD
TIME STUDY – DO NOT DISTURB”. Take adequate precautions during status labelling to
prevent adding microbial load to the equipments. The status label shall also bear the date on
which the equipments were transferred to the cleaning area and the Product / Batch No
which was last manufactured using these equipments.
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PROTOCOL FOR CHECKING THE PHOTOSTABILITY OF NEUROBION FORTE RF

INJECTION UNDER THE INFLUENCE OF SODIUM VAPOR LAMPS

Used duster should be placed in a suitable container during the hold time study and the
container along with the duster should be stored in the duster washing area.

All these unclean equipments should be kept as such for 3 days. After three days of holding,
swabs should be collected again as mentioned above.
Note down the equipment name, date of use and date of sampling in the Annexure I.

Send the test tubes containing the swab samples to QC with covering of two layers of butter
paper. The swab samples are to be tested for microbial count only as per procedure for swab
test analysis.
To each swab add 5 ml of sterile 0.05% Polysorbate 80 [Tween 80] prepared in saline
solution. Pipette out 1ml each a sterile Petri dish and add to it 15 to 20 ml of Soyabean
HiVeg agar. Swirl to mix and then allow to solidify. Incubate the plates at 34 C  1C for 48
hours.
Record the results of the testing in respective format

In case a high count is obtained after 3 days of holdings then the next set of testing shall be
repeated by proportionately reducing the hold time period. If results are satisfactory then the
experiment is to be repeated two more time with the revised hold time period.

The study for hold time study of uncleaned equipments is to be done three consecutive
times.

4.2 Procedure for cleaned equipments

For determining the hold time of cleaned equipment Purified water is used for sampling
instead of swabs. This is done because the cleaned equipment are free of oily residues and
rinse sampling is preferred as more surface are a can be covered.

In case of duster used for capsule drying swabs sampling technique shall be used instead of
rinse sampling. Initial sample shall be collected after washing and drying of the dusters.
Sample after 6 days shall be collected from the same duster stored in the storage container.

While sampling wear gloves which are disinfected, clean over gown, head gear and nose
mask.

After the equipments are washed and transferred to cleaned equipment storage area, rinse
the cleaned equipments with about 500 ml of Purified water. Collect about 200ml of this
rinse sample in a previously sterilised 250 ml capacity screw cap glass bottle. Rinse of each
equipment is to be collected in separate sterilised screw cap bottles.
During rinsing difficult to clean areas shall be considered.

Screw cap glass bottles should be sterilized in QC Microbiology section. The sterilised bottles
should be covered with two layers of butter paper before taking it to Softgel department.
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PROTOCOL FOR CHECKING THE PHOTOSTABILITY OF NEUROBION FORTE RF

INJECTION UNDER THE INFLUENCE OF SODIUM VAPOR LAMPS

Remove one layer of butter paper in airlock and last one in production office before taking
the bottles for sample collection.

Purified water for rinsing is to be collected in a 500 ml capacity wash bottle that is previously
disinfected with disinfectant solution. Record the disinfection of the wash bottle.

These cleaned equipments after sampling shall be dried and then labelled with the status
label as “UNDER HOLD TIME STUDY – DO NOT DISTURB” and stored for a period of 6 days in
cleaned equipment storage area. Take adequate precautions during status labelling to
prevent adding microbial load to the equipments.
After 6 days of holding again collect the rinse sample as describes above and sent to QC for
analysis.

The rinse samples are to be tested for microbial count only as per procedure defined in Doc.
No. 12041.
Also determine the count of Purified water used for the rinsing so as to serve as a blank.
Record the results of the testing in format No. F12041/01/06.

In case a high count is obtained after 6 days of holdings then the next set of testing shall be
repeated by proportionately reducing the hold time period. If results are satisfactory then the
experiment is to be repeated two more time with the revised hold time period.

The study for hold time study of cleaned equipments is to be done three consecutive times.

5. ACCEPTANCE CRITERIA

Initial microbial count shall not be more than 100 cfu per rinse sample.

The microbial count should not proliferate above the release limit of 100 cfu/rinse sample
during the hold time period.

6. FREQUENCY

This is a one-time validation to determine the hold time of cleaned and unclean
manufacturing equipments.

7. SUPPORTING DOCUMENTS

Annexure I : List of uncleaned Equipments

Annexure II : List of cleaned Equipments
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PROTOCOL FOR CHECKING THE PHOTOSTABILITY OF NEUROBION FORTE RF

INJECTION UNDER THE INFLUENCE OF SODIUM VAPOR LAMPS

Note: This protocol is prepared for the first time.