NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/6.

1
QUALITY STANDARD OPERATING PROCEDURE- ISSUE NO: 01
MANAGEMENT
SYSTEM PRODUCTION ISSUE DATE:-15/07/10
Antiseptic non adherent dressing
PAGE 1 OF 3
Povidone iodine USP non adherent tulle dressing

1.0 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 Chlorhexidene ointment

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. Add PEG 4000 into the main vessel
vi. Maintain the temperature of vessel within 60 0 to 70 0 by regulating in out valve
vii. Record the temp.
viii. Run mixer. Allow to mix for 45-60 minutes. Still a homogenous solution observed as transparent
liquid
ix. Take PEG 400 & Distil water in separate SS storage tank.

x. Discard 1/2 qty of PEG 400 from the main vessel into another SS Vessel. and set the mixture in
remi stirrer and allow to run remi stirrer
xi. Disperse the Povidone iodine slowly through spoon carefully very slowly in the duration of 100-
120 minutes.
xii. Transfer the mixture into main vessel, clean thoroughly with successive mixture discarded from
storage tank. (Ensure no substance should loss) by successive washing by PEG 400 AND water.
PREPARED APPROVED ISSUED
REVISION HISTORY
BY BY BY
REV.NO
ISO 13485:2003
DATE
PM CEO MR
 NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/6.1
QUALITY STANDARD OPERATING PROCEDURE- ISSUE NO: 01
MANAGEMENT
SYSTEM PRODUCTION ISSUE DATE:-15/07/10
Antiseptic non adherent dressing
PAGE 2 OF 3
Povidone iodine USP non adherent tulle dressing

xiii. Close in let valve of steam line and open inlet of water supply allows circulating of water.
xiv. Then run the stirrer of main vessel in ist gear for 20 minutes.
xv. When the mixture observed as Ointment form & attaining temp 30-35 0 continue the stirring for
another 30 minutes with IIND Gear.
xvi. Stop stirrer
xvii. Close inlet outlet valve and discard the Ointment in clean ss tank and cover with lid.
Put a label mentioning B.NO and Mfg. date.
xviii. Submit a sample of appx . 100 gm of ointment to Q.C FOR ANALYSIS.
xix. Obtain the result from q.c for following parameters
1. Appearance : Shall be clear dark brown ointment
2. Identifications : Shall Positive for Povidone Iodine
3. Available Iodine : % (w/w) 1.0 to 1.3

Precaution: Dont exceed the temperature more than 700 C.

Spreading of Povidone Iodine Ointment

i. Ensure the cleaning and mopping with IPA immersed tissue paper.
ii. Open the air valve.
iii. Switch on the main switch.
iv. Place and fit the Fabric (Rayon Fabrics) at the unwind roller.
v. Place two rolls of HDPE Film roll in the aligned manner and fit above and below the coating box.
vi. Insert the Fabric through coating box at the middle of the box and adjust the blade at minimum
level.
vii. Then pour the Ointment / meant to coating.
viii. Forward about 30cm dressing i.e., through proper laminating and ensure both the HDPE film are
aligned in parallel manner with the fabrics.
ix. Run the machine manually by pressing the inch/ sear button.
x. Ensure the holding and cutting of dressing is proper.
xi. Check the GSM of samples and wait for QC Clearance.
xii. Press start button.
xiii. Then machine will run automatically.
xiv. For single Piece of 10cm dressing set the counter at 2.
xv. Set the temperature at 40-500 C of the coating plate.
xvi. Adjust the GSM of the ointment up and down by the screw of the Front Plate.

PREPARED APPROVED ISSUED

REVISION HISTORY
BY BY BY
REV.NO
ISO 13485:2003
DATE
PM CEO MR
 NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/6.1
QUALITY STANDARD OPERATING PROCEDURE- ISSUE NO: 01
MANAGEMENT
SYSTEM PRODUCTION ISSUE DATE:-15/07/10
Antiseptic non adherent dressing
PAGE 3 OF 3
Povidone iodine USP non adherent tulle dressing

xvii. The machine runs pneumatically and various Pneumatic cylinders are operated through Solenoid
valve.
xviii. 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. (Packing)

i. Stamp details of Batch NO, Mfg Date etc on Pouch .
ii. Using clean hand gloved hand, open the 2 sides of sealed pouches manually and Insert the
dressing with forceps.
iii. Set the temperature of sealing machine at 250-300 0 C
iv. Allow to seal properly to open end. Through sealing machine. The sealing operation shall be
carried under strict supervision to ensure proper sealing. (Check the seal strength)
v. 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.

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

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

v. 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.
vi. 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).mention Products Name, Batch No, Mfg Dt, Exp Dt,
Qty;
vii. Then transfer the goods though successive GTN.

PREPARED APPROVED ISSUED

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