Neptune Orthopaedics Standard Operating Procedure-Production

NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/02
QUALITY
MANAGEMENT STANDARD OPERATING PROCEDURE- ISSUE NO: 01
SYSTEM
PRODUCTION ISSUE DATE:-15/07/10
ELASTIC ADHESIVE BANDAGE B.P PAGE 1 OF 4
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 adhesive mass; Sigma machine 1 Size of mass: 20-60 kg.
i. All materials release should be issued.

ii. All materials must be weighed accurately in presence of chemist as per master formulation
iii. And store person
iv. Sigma machine should be clean check for run.
v. Observe all safely measures especially wrt fire system. And circulation of cooling water in
jacket.
vi. Transfer 10-15 ltr of solvent into sigma mixer.
vii. Run mixer in reverse and add zinc oxide and ZDEC and close the lid, run for 15 minutes.
viii. Open the lid and charge rubber pieces (previously teared into small pieces appx. less than
sq.ft.) Slowly within 10min. and close the lids allow running for 10 minutes.
ix. Stop the machine and run the machine in forward direction for 2 hrs. for mix.
x. Add lanolin in installment in each 30 minute.
xi. Add 5 ltr of n hexane and allow running for 10 minutes.
xii. Add rosin in installment of 3 times with additional qty of hexane of 3 ltr in each time.
xiii. Then allow running and subsequently adding 5 ltr. of hexane in 15 minutes difference.
xiv. Observe visually by overflowing the mass by big spoon from the height about 2 ft. from sigma.
xv. If the mass feels of meet requirement hen send the samples to QC for check of solid content.
xvi. The solid content should be 75-85%
PREPARED APPROVED ISSUED

REVISION HISTORY
BY BY BY
REV.NO
ISO 13485:2003
DATE
PM CEO MR
QUALITY
SYSTEM
xvii. If solid content is within limit then allow the mass to discharge into storage container, by
mentioning the batch No. Mfg. date Gross weight and net weight.
xviii. If the solid content is more than 85% the chemist shall adjust by adding successive qty of
hexane; allowing running of sigma for another certain time. And recheck the solid content. In
each steps actual time to be note in BMR.
Preparation of adhesive mass: Sigma machine II size of mass 60-150 Kg.
i. All materials released should be issued.

ii. All materials must be weighed accurately in presence of chemist as per master formulation
iii. And store person.
iv. Sigma machine should be clean check for run.
v. Observe all safety measures especially wrt fire system. And circulation of cooling water in
jacket.
vi. Transfer n-hexane to sigma.
vii. Run mixer and add zinc oxide & zdc. Allow to mix for 25 minutes by close the lid.
viii. Stop mixer charge CO2 for 30 Sec.
ix. Stop mixer, open the lid of the sigma and charge rubber pieces loosely and allow running mixer
for 3 Hrs. Ensure no mottles of rubber shall observe at the end of this procedure. If mottles
observed add 1 2 ltr, n-hexane and run for another 30 minutes.
x. Stop mixer, Add dry mass if any of previous mass and mix to 30 min.
xi. Stop mixer add th qty of rosin and allow running for 15 minutes by repeating these procedure
add all rosin in installment.
xii. Stop mixer and add lanolin anhydrous. Run for 30 Minute.
xiii. Add n hexane 10 liter. Mix for 10 min. Repeat and addition of hexane with a small volume
mentioning time & qty till require viscosity by addition hexane or to allow run for more time.
xiv. Observe visually by overflowing the mass by big spoon from the height about 2 ft form sigma.
REVISION HISTORY
BY BY BY
REV.NO
ISO 13485:2003
DATE
PM CEO MR
QUALITY
SYSTEM
xv. If the mass feels of meet requirement then send the samples to QC for check of solid content.
xvi. The solid content should be 75-85 %.
xvii. If solid content is within limit then allow the mass to discharge into storage container, by
mentioning the batch No. Mfg. Date gross weight and net weight.
xviii. If the solid content is less than 75% the chemist shall adjust by allowing running of sigma for
another certain time. And recheck the solid content.
xix. If the solid content is more than 85% chemist shall adjust by adding successive qty of hexane;
allowing running of sigma for another certain time. And recheck of solid content.
In each steps actual time to be note in BMR.
Coating of Adhesive Mass.

Before starting coating process dryer temp has to reach, and maintain temp within 90-
120 OC.
Ensure the running of machine by switch on. And check
The exhaust systems and blower for smooth run.
1.1.1. Clean the coating box, with solvent.
1.1.2. Fit the blades with box. Fix the blades securely by tightening the bolts.
1.1.3. As per the size of the crepe fix the border with proper alignment by putting
Putting tow plates of aluminum sheet of 2mm thick. And two pieces of plastic
Strip of about 2 to 2.5cm width.
1.1.4. Insert the crepe to be coated through the coating box.
1.1.5. Fill the over head hopper with adhesive mass and mount it just above coating box.
1.1.6. Open the outlet of the hopper allow the mass to fill 2/3rd of the coating box.
1.1.7. Adjust the margin for coating by moving the plastic strip.
1.1.8. Adjust the gap between the base plate and the doctor blade so required amount of mass is
coated on the cloth.
1.1.9. Start the machine.
1.1.10. Pass the coated cloth on a slit through which compressed air is passed.
1.1.11. Pass the coated cloth through a heating tunnel with the help of conveyor belf.
1.1.12. Pass the coated and perforated plast through cooling tunnel.
1.1.13. Coated past after conditioning through cooling chamber is laminated with siliconised film and
the winding takes place.
1.1.14. Submit the samples to Q.C. for clearance.
1.1.15. Continue the coating after the clearance from QC.
1.1.16. Continue the coating under supervision of in process QC Chemist.
1.1.17. Each coated roll is measured though dial meter. And the dial meter, Batch No, Roll No, are
labeled on winded roll.
1.1.18. Allow to conditioning the roll in AC room for at lest 8 hrs.
REVISION HISTORY
BY BY BY
REV.NO
ISO 13485:2003
DATE
PM CEO MR
QUALITY
SYSTEM

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

Neptune Orthopaedics Standard Operating Procedure-Production

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NEPTUNE ORTHOPAEDICS DOC NO: NO/SOP-P/02

5.0 DEFINITIONS: Nil

Preparation of adhesive mass; Sigma machine 1 Size of mass: 20-60 kg.

i. All materials release should be issued.

PREPARED APPROVED ISSUED

Preparation of adhesive mass: Sigma machine II size of mass 60-150 Kg.

i. All materials released should be issued.

Coating of Adhesive Mass.

PREPARED APPROVED ISSUED

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