NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/

QUALITY
MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
SYSTEM
PRODUCTION ISSUE DATE:-15/07/10
PARAFFIN GAUZE DRESSING B.P PAGE 1 OF 3

PURPOSE:
The purpose of this procedure is to define and control critical activities in production as per the
requirement of ISO 13485: 2003.

2.0 SCOPE:
This procedure covers standard operating procedure of the concerned area in production.

3.0 RESPONSIBILITY:
Refer Responsibility & authority chart NO/QSM/AX04.

4.0 APPROVAL:
This procedure is approved by CEO and can be amended only by him.

5.0 DEFINITIONS: Nil

6.0 PROCEDURE:

Preparation of JELLY (Paraffin mass)

i. All materials release should be issued.

ii. All materials must be weighed accurately in presence of chemist as per master formulation
And store person
iii. Ointment /jelly mixer (jacketed should be clean check for run.
iv. Observe all safely measures especially wrt fire system, circulation of steam & of cooling water in
jacket.
v. Transfer Petroleum jelly and hard paraffin to mixing tank.
Open the steam by regulating in out valve and take temperature in between 60-70 0 C
vi. Record the temp.
vii. Run mixer. Allow to mix for 45-60 minutes. Still a homogenous solution observed as transparent
liquid
viii. Close in let valve of steam line and open inlet of water supply allows circulating of water.
ix. When the mixture observed as jelly form stop stirring
x. Close inlet outlet valve and discard the jelly in clean ss tank and cover with lid.
Put a label mentioning B.NO and Mfg. date.

* If the batch is plan for multi packing i.e. for 10pcs or 20 pcs spreading purpose allow jelly to remain
in mixing tank

PREPARED APPROVED ISSUED

REVISION HISTORY
BY BY BY
REV.NO
ISO 13485:2003
DATE
PM CEO MR
 NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/
QUALITY
MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
SYSTEM
PRODUCTION ISSUE DATE:-15/07/10
PARAFFIN GAUZE DRESSING B.P PAGE 2 OF 3

Precaution: Dont exceed the temperature more than 700 C

Spreading of jelly /dosing of jelly- For single Ply Dressing.

1) Ensure the cleaning and mopping with IPA immersed tissue paper.
- Open the air valve.
- Switch on the main switch.
2) Place and fit the Fabric (leno / Rayon Fabrics) at the unwind roller.
3) Place two rolls of PVP roll or HDPE film roll in the aligned manner and fit above and below the
coating box.
4) Insert the Fabric through coating box at the middle of the box and adjust the blade at minimum level.
5) Then pour the Ointment / Jelly meant to coating.
6) Forward about 30cm dressing i.e., through proper laminating and ensure both the PVP film are
aligned in parallel manner with the fabrics.
7) Run the machine manually by pressing the inch/ sear button.
8) Ensure the holding and cutting of dressing is proper.
9) Check the GSM of samples and wait for QC Clearance.
10) Press start button.
11) Then machine will run automatically.
12) For single Piece of 10cm dressing set the counter at 2 and for single Piece of 20cm set the counter at
3.
13) Set the temperature at 50-600 C if it is required in case of Paraffin Jelly and Chlrohexedine ointment.
to give heating to coat the plate.
14) Adjust the GSM of the ointment up and down by the screw of the Front Plate.
15) The machine runs pneumatically and various Pneumatic cylinders are operated through Solenoid
valve.
16) Adjust the moving of the cylinders action to slow or speedy through regulating the solenoid valve
through skilled operators or through supervisor or through the concerned maintenance person

Feeling Of dressing & Sealing.

Insert the dressing into previously coded tetra laminate pouch, by carefully open through forcep.
Set the temperature of sealing machine at 150-160 0 C
Allow to seal properly to open end. Through sealing machine. The sealing operation shall be carried
und strict supervision to ensure proper sealing. (perform leak test)
LEAK TEST.

PREPARED APPROVED ISSUED

REVISION HISTORY
BY BY BY
REV.NO
ISO 13485:2003
DATE
PM CEO MR
 NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/
QUALITY
MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
SYSTEM
PRODUCTION ISSUE DATE:-15/07/10
PARAFFIN GAUZE DRESSING B.P PAGE 3 OF 3

After running of sealing in continuous take at least 8 pouch and place in oven previously temp set at
150 0 C in vertical manner so that each side of two pouch should be face at bottom.allow to the
treatment for 30 minutes.
AFTER 30 MINUTES CHECK EACH SIDE : NO LEAKAGE SHALL BE OBSERVED.

Continue sealing, no mottling delorination at sealing end shall observed.

Packing For Sterilization process& Final Packing.

1. Insert 10 such pouches into previously coded and checked duplex box.
2. Rearrange the duplex box into sterilization shipper upto 14 kg.
3. Label the shipper: Products Name:_________ Batch No_______ Mfg. Dt.__________ .
4. & Make SFGTN.

5. Send the materials to M/S Universal Medicap Ltd. Baroda for the irradiation Process.

6. After Receive of the irradiated dressing along with irradiation certificates, 20 samples for sterility
testing shall be issued. & Raise QC REALEASE Form to qc for the goods.
7. After release of the dressing make 5 duplex boxes in unit to warp in shrink. And allow 16 such
bundle in a shipper. And label the Shipper).motioning Products Name, Batch No, Mfg Dt, Exp Dt,
Qty;
8. Then transfer the goods though successive GTN.

PREPARED APPROVED ISSUED

REVISION HISTORY
BY BY BY
REV.NO
ISO 13485:2003
DATE
PM CEO MR