POLY MEDICURE LIMITED

TECHNICAL FILE
TITLE : THREE WAY STOP COCK
DOCUMENT NO.

DATE

: TF/IVC/02

REVISION NO.: 04

: 07.06.2006

ISSUE NO.

: 05

PAGE NO.

: 01 of 07

PURPOSE

1.

1.1

This document describes the product design and technical requirements of

the Three Way Stop Cock range of products. As per Council Directive
93/42/EEC of 14 June 1993 concerning medical devices the family of
Three Way Stop Cock is classified as Class IIa. Three Way Stop Cock
Family should comply with essential requirements of Medical Devices
Directive 93/42/EEC.

INTENDED USE OF PRODUCT

2.

2.1

The product is used to deliver Intravenous fluid and medicines into

human circulating system.

PRODUCT DESCRIPTION

3.

3.1

Three Way Stop Cock -The Three Way Stop Cock family is designed to
provide access into IV Cannula system for administration of two fluids or
drugs at a time. Based on the application and requirements, various
features are incorporated in the Three Way Stop Cocks design as follows:
3.1.1 Three Way Stop Cock
3.1.2 Three Way Stop Cock (Lipid Resistant)
3.1.3 High Pressure Three Way Stop Cock
3.1.4 Three Way Stop Cock with Extension Tube.

REFERENCE DOCUMENTS

4.

S. No.
4.1

Document Code
ISO 9001:2000

4.2

ISO 13485:2003

4.3
4.4
4.5

93/42/EEC
ISO 14971: 2000
ISO 10993- 7

4.6

ISO 594-1

4.7

ISO 594-2

4.8

ISO 11135 / EN 550

4.9

ISO 15223 / EN 980

Document Description
Quality management system Requirements
Quality system Medical Devices Requirements for the
Regulatory Purposes
European Council Directive
Risk analysis
Ethylene oxide sterilization residuals
Conical fittings with a 6% (luer) taper for syringes, needles
and certain other medical equipment - Part 1
Conical fittings with a 6% (luer) taper for syringes, needles
and certain other medical equipment - Part 2 : Lock Fittings
Validation and routine control of EO Sterilization
Symbols to be used with medical devices labels, labeling and
information to be supplies

PREPARED BY

APPROVED BY

ISSUED BY

(Sr. officer - QA)

(SGM QA)

(M. R.)

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POLY MEDICURE LIMITED

Title

: Three Way Stop Cock

Revision No. : 04

Document No.: TF/IVC/02

Issue No.

: 05

Date

Page No.

: 02 of 07

: 07.06.2006

S. No.
4.10
4.11
4.12
4.13
4.14
4.15
4.16
4.17
4.18
4.19
4.20
4.21
4.22
4.23

4.24
4.25
4.26
4.27
4.28
4.29

5.

Document Code

Document Description

USP / IP
FP/QA/05
WI/IVC/11
WI/IVC/12
WI/IVC/14
WI/IVC/15
WI/QA/17
QP/QPL/01
FP/QA/02
WI/QA/26
WI/IVC/25
Drg. No. ASSY - 1006
Drg. No. ASSY - 1008
Drg. No. COMP. 1001.01
Drg. No. COMP. 1006.01
Drg. No. COMP. 1006.02
Drg. No. COMP. 1006.03
Drg. No. COMP. 1006.04
Drg. No. COMP.1012.01
Drg. No. COMP.1012.03

United States Pharmacopoeia / Indian Pharmacopoeia

Process Control -Three Way Stop Cock
Handle and Channel Assembly
Leakage checking of handle and channel assembly
Fixing of Screw Cap, Cock Cap & Extension Tube
Final Inspection
Sterility Test
Quality Planning
Finished product testing of Three Way Stop Cock
Validation of ETO sterilizer
Routine operation and monitoring of ETO sterilizer
Assembly Three Way Stop Cock
Three Way Stop Cock with Extension Tube
Luer Lock
Handle
Channel (Polyway)
Screw Cap
Cock Cap
Male luer connector
Luer connector cap

SHELF LIFE
5.1

6.

The Finished products shall conform to the specifications and functional

requirements for a minimum of five years from the date of sterilization.

STERILIZATION
6.1

Sr. No.
1

2.

Product shall be sterilized with Ethylene Oxide (EO) gas as per standardized and
validated sterilization cycle as per ISO 11135 / EN 980, WI/QA/26 and routine
monitoring cycle is carried out as per WI/IVC/25. The medical grade paper is
designed to allow maximum exchange of ethylene oxide, air and moisture. For
detailed validation report refer to QA department. Based on validation result the
routine cycle for sterilization is summarized as follows: Particular

Limit

Preconditioning
(i)
Time
(ii)
Temperature of chamber
(iii)
Humidity
Conditioning
(i)
Vacuum drawn rate
(ii)
Vacuum holding time
(iii)
Temperature of chamber
(iv)
Humidity of chamber

60 minute
45C ( 5C)
45% ( 15%)
-26 inch @ 35 5 min.
20 minute
45C ( 5C)
40% ( 15%)

PREPARED BY

APPROVED BY

ISSUED BY

(Sr. officer - QA)

(SGM QA)

(M. R.)

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POLY MEDICURE LIMITED

Title

: Three Way Stop Cock

Revision No. : 04

Document No.: TF/IVC/02

Issue No.

: 05

Date

Page No.

: 03 of 07

: 07.06.2006

S. No.
3

Particular
Sterilization
(i)
EO gas inlet temperature
(ii)
Concentration of EO gas
(iii)
Temperature of chamber
(iv)
Temperature of product
(v)
Humidity of chamber
(vi)
Humidity of product
(vii)
Exposure time

4.

Aeration
(i)
Vacuum drawn rate
(ii)
Total number of aeration

Limit
Not less than 20C
450 mg / Liter.
50C ( 5C)
50C ( 5C)
45% ( 15%)
45% ( 15%)
360 minute
-21 inch @ 25 5min.
3 nos.

The detailed record of routine monitoring is maintained with the QA as

well as production department.

7.

6.2

Product appearance and functional performance is not compromised by up

to three EO sterilization cycles as the product is sterilized three times and
the package of product remained intact. The ethylene oxide residue was
also found within limit.

6.3

Revalidation is done once in a year. The calibration of instruments like

pressure gauge, temperature gauge, temperature indicator and controller,
PT 100 etc. are done time to time as per their due date of Re - calibration.

MATERIAL
7.1

All component materials should be such that components and product

assemblies will pass material testing as specified in specifications.
Part Where
Material is used

S. No.

Base Material

Grade

Vendor

1
2

Luer Lock
Channel Housing

HDPE
Polycarbonate

50 MA 180
Caliber 201-15

IPCL
LG Dow

Channel Housing (Lipid)

Polycarbonate (macrolon)

R.1500

Bayer

4
5

Handle
Screw Cap

HDPE
Polycarbonate

50 MA 180
Caliber 201-15

IPCL
LG Dow

6
7

Cock Cap
PVC tubing

Polypropylene
PVC

SM 668
IP 31

Titan - pro
Indel polymers

8
9

Male luer connector

Connector cap

Polycarbonate
Polypropylene

Caliber 201-15
SM 668

LG Dow
Titan - pro

10

Unit Package Lid (Paper)

1059 B

Amcor

11

Unit Package Lid (Tyvek)

Medical Grade Grid Lacquered

Paper
Tyvek

1073B

Perfexy

12

Unit Package Blister

PVC Film

NA

Caprihans

PREPARED BY

APPROVED BY

ISSUED BY

(Sr. officer - QA)

(SGM QA)

(M. R.)

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POLY MEDICURE LIMITED

Title

: Three Way Stop Cock

Revision No. : 04

Document No.: TF/IVC/02

Date

: 07.06.2006
Part Where
Material is used

S. No.
13
14
15
16

8.

Issue No.

: 05

Page No.

: 04 of 07

Grade

Vendor

Base Material

Duplex Box
Duplex Box Label
Shipper Box (Big / Small)
EO Gas

Printed Paperboard
Adhesive Paper
Corrugated Paperboard
10% EO & 90% CO2

NA
NA
NA
NA

Devsaro
Various
Poly Pack
P.C.I.

COMPONENT AND PROCEDURE FOR ASSEMBLY

8.1

Three Way Stop Cock / Three Way Stop Cock (Lipid Resistant) /
High Pressure Three Way Stop Cock
8.1.1 Component
(i)
Luer Lock Plug
(ii)
Handle
(iii)
Channel
(iv)
Screw Cap
(v)
Cock Cap

Drg. No. COMP. 1001.01

Drg. No. COMP. 1006.01
Drg. No. COMP. 1006.02
Drg, No. COMP. 1006.03
Drg, No. COMP. 1006.04

8.1.2 Assembly

8.2

(i)

Handle and Channel Assembly - The assembly of handle

with channel is done as per WI/IVC/11.

(ii)

Fixing of Cock Cap & Screw Cap -The cock cap and screw
cap are assembled as per WI/IVC/14.

(iii)

Final Inspection - The final inspection of the product is

done as per WI/IVC/15.

Three Way Stop Cock with Extension Tube

8.2.1 Component
(i)
Luer Lock
(ii)
Channel
(iii)
Handle
(iv)
Male Luer connector
(v)
luer connector cap
(vi)
PVC tubing

Drg. No. COMP. 1001.01

Drg. No. COMP. 1006.02
Drg. No. COMP. 1006.01
Drg, No. COMP. 1012.01
Drg, No. COMP. 1012.03

PREPARED BY

APPROVED BY

ISSUED BY

(Sr. officer - QA)

(SGM QA)

(M. R.)

PDF created with pdfFactory trial version www.pdffactory.com

POLY MEDICURE LIMITED

Title

: Three Way Stop Cock

Document No.: TF/IVC/02

Date

: 07.06.2006

Revision No. : 04
Issue No.

: 05

Page No.

: 05 of 07

8.2.2 Assembly
(i)

(ii)

(iii)

8.3

Handle and Channel Assembly - The assembly of handle

with channel is done as per WI/IVC/11.
Gluing of tube with channel and Male luer connector - The
tube is glued with Three Way Stop Cock and Male luer
connector as per WI/IVC/14.
Final Inspection - The final inspection of the product is
done as per WI/IVC/15.

Environment for assembly of product

The product is manufactured in clean room controlled conditions. The
clean room is class 100,000 meeting requirements set by Federal Standard
209E for Clean Room. Clean rooms are provided with high efficiency
particulate air filter (HEPA) and controlled temperature and humidity.
Clean rooms are validated frequently for efficiency of HEPA filter as per
the schedule laid down under procedure QP/IMT/01. The area is
maintained as per WI/IVC/02.
The clean rooms are continuously monitored for environmental bio burden
by using settling plate method. The bio burden method, frequency and
limit of colony forming unit (CFU) are defined in WI/QA/08.
The bio burden on the equipment, fixture, dresses of workers etc is also
frequently monitored. The bio burden method, frequency and limit of
colony forming unit (CFU) are defined in WI/QA/08.

PREPARED BY

APPROVED BY

ISSUED BY

(Sr. officer - QA)

(SGM QA)

(M. R.)

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POLY MEDICURE LIMITED

9.

Title: Three Way Stop Cock

Revision No. : 04

Document No. : TF/IVC/02

Issue No.

: 05

Date

Page No.

: 06 of 07

: 07.06.2006
FUNCTIONAL SPECIFICATIONS
9.1

Three Way Stop Cock / Three Way Stop Cock (Lipid Resistant) / High
pressure Three Way Stop Cock
9.1.1 Luer Lock Plug
Also known as Luer Lock Cap.
Male Luer Lock design to comply with ISO 594 2
External gripping features.
9.1.2 Channel / Handle Assembly
The channel and handle assembly is done as per
WI/IVC/11 should have a locking fit so that the handle
does not come out of the channel after assembly and there
is no leakage in the channel and handle assembly.
The channel should have female luer lock connection as per
ISO 594 -1 at two ends.
The channel and handle assembly shall be leak proof when
tested in accordance with WI/IVC/12 and Annexure A of
FP/QA/05.
9.1.3 Luer Connections
Male and female connection of channel shall confirm to
ISO 594 - 1 and ISO 594-2. The connections are tested
frequently using calibrated male and female gauge.

9.2

Three Way Stop Cock with Extension Tube

9.2.1 Luer Lock Plug Please refer to clause 8.1.1
9.2.2 Channel / Handle Assembly Please refer to clause 8.1.2
9.2.3 Male connector
The Male luer connection shall comply ISO 594 2
Shall make a leak proof connection with the tubing.
The male part of the connector shall be covered with
protective cap.
9.2.4 Y connector
The Y-connector is provided with injection site and both
side connected with delivery tube with leak proof joints.
The Y-connector must be transparent and free from any
damage or foreign particle

PREPARED BY

APPROVED BY

ISSUED BY

(Sr. officer - QA)

(SGM QA)

(M. R.)

PDF created with pdfFactory trial version www.pdffactory.com

POLY MEDICURE LIMITED

Title: Three Way Stop Cock

Revision No. : 04

Document No. : TF/IVC/02

Issue No.

: 05

Date

Page No.

: 07 of 07

: 07.06.2006

9.2.5 Tubing connection with channel and female connector

Tubing shall make a leak proof connection with both the
end i.e. male and female connector.
Length of tubing shall be between 5 cm to 250 cm as per
requirement.
The tubing shall be kink resistant & transparent or
sufficiently translucent to monitor the passage of fluid.
The tubing at the joint of male and female connector shall
withstand specified tensile force.
10.

11.

CLASSIFICATION
10.1

Three Way Stop Cock

As per Classification Criteria in Annexure IX of the Council Directive

93/42/EEC the Three Way Stop Cock and Three Way Stop Cock with
Extension Tube is normally intended for continuous use for more than 60
minutes and less then 30 days. Hence it is for short-term use as per
description in the 1.1 of Annexure IX)

This device does not penetrate inside the body, hence is Non invasive
device.

Three Way Stop Cock and Three Way Stop Cock with Extension Tube
may be used for channeling of Blood or other body liquids. So as per rule
2 of classification, Three Way Stop Cock and Three Way Stop Cock with
Extension Tube is class IIa Medical Device.

QUALITY PLAN
11.1

A three tier Quality Plan is followed consisting of the Quality System

Manual, the Standard Operating Procedures (SOPs) and Work Instructions
and Formats.

11.2

These take care of all the functional responsibilities of the management

and company employees, production and quality control at various stages.
It also takes care of the Quality Assurance needs and compliance with the
various national and international standards and regulations. Quality
planning is done as per QP/QPL/01.

11.3

The Quality Plan covers all incoming, inprocess and finished products.
The control and process are defined in the SOPs and Work Instructions
and the observations are recorded in Formats and Registers.

PREPARED BY

APPROVED BY

ISSUED BY

(Sr. officer - QA)

(SGM QA)

(M. R.)

PDF created with pdfFactory trial version www.pdffactory.com