You are on page 1of 3

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

date. Submit a sample of appx . iv. Place two rolls of HDPE Film roll in the aligned manner and fit above and below the coating box. Ensure the cleaning and mopping with IPA immersed tissue paper. Close inlet outlet valve and discard the Ointment in clean ss tank and cover with lid. ii. x. vii. xiv. Obtain the result from q. Forward about 30cm dressing i. iii.0 to 1. 100 gm of ointment to Q. Identifications : Shall Positive for Povidone Iodine 3. Place and fit the Fabric (Rayon Fabrics) at the unwind roller. Run the machine manually by pressing the inch/ sear button. xiv. Available Iodine : % (w/w) 1. When the mixture observed as Ointment form & attaining temp 30-35 0 continue the stirring for another 30 minutes with IIND Gear.C FOR ANALYSIS. Then run the stirrer of main vessel in ist gear for 20 minutes.3 Precaution: Don’t exceed the temperature more than 700 C. ix. For single Piece of 10cm dressing set the counter at 2. Check the GSM of samples and wait for QC Clearance. xvi. PREPARED APPROVED ISSUED REVISION HISTORY BY BY BY REV. Close in let valve of steam line and open inlet of water supply allows circulating of water. Adjust the GSM of the ointment up and down by the screw of the Front Plate. Appearance : Shall be clear dark brown ointment 2. Ensure the holding and cutting of dressing is proper. xi. Press start button. xix.NO and Mfg. xiii. xii. Insert the Fabric through coating box at the middle of the box and adjust the blade at minimum level.1 QUALITY STANDARD OPERATING PROCEDURE. Spreading of Povidone Iodine Ointment i. xv. Switch on the main switch. through proper laminating and ensure both the HDPE film are aligned in parallel manner with the fabrics. Put a label mentioning B.. viii. 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. NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/6. xviii. xvi. v. Then pour the Ointment / meant to coating. Then machine will run automatically. vi. xv.NO ISO 13485:2003 DATE PM CEO MR .c for following parameters 1.e. Set the temperature at 40-500 C of the coating plate. Stop stirrer xvii. Open the air valve.

Using clean hand gloved hand. Batch No. 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. AFTER 30 MINUTES CHECK EACH SIDE : NO LEAKAGE SHALL BE OBSERVED. open the 2 sides of sealed pouches manually and Insert the dressing with forceps.NO ISO 13485:2003 DATE PM CEO MR . Mfg Date etc on Pouch . Then transfer the goods though successive GTN. Through sealing machine. no mottling delorination at sealing end shall observed. vi. 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. Stamp details of Batch NO. The sealing operation shall be carried under strict supervision to ensure proper sealing. Label the shipper: Products Name: _________ Batch No_______ Mfg. i. 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. NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/6. iii. (Check the seal strength) v. Allow to the treatment for 30 minutes.mention Products Name. Exp Dt. iii. iv. Continue sealing. Set the temperature of sealing machine at 250-300 0 C iv. vii.1 QUALITY STANDARD OPERATING PROCEDURE.__________ & Make SFGTN. xviii. (Packing) i. v. 20 samples for sterility testing shall be issued. Packing For Sterilization process& Final Packing. And label the Shipper). After Receive of the irradiated dressing along with irradiation certificates. Baroda for the irradiation Process. Send the materials to M/S Universal Medicap Ltd. Allow to seal properly to open end. Dt. The machine runs pneumatically and various Pneumatic cylinders are operated through Solenoid valve. After release of the dressing make 5 duplex boxes in unit to warp in shrink. ii. & Raise QC REALEASE Form to QC for the goods. Rearrange the duplex box into sterilization shipper upto 14 kg. Insert 10 such pouches into previously coded and checked duplex box. ii. Qty. And allow 16 such bundle in a shipper. Mfg Dt. PREPARED APPROVED ISSUED REVISION HISTORY BY BY BY REV.

Related Interests