Intravenus Cannulla Manufacturing Procedure

REVITAL HEALTH EPZ LIMITED
INTRAVENOUS CANNULA PROCEDURE
APPROVED BY
REVISIONS TABLE
REVISION REVISE DESCRIPTION DATE

NUMBER D
PAGE(S)
0 0 Original Issue 18/06/2018
1. PURPOSE:
To ensure that all the intravenous cannula with or without wings and with or without
injection port are manufactured in a safe manner and ensure they meet all legal
and regulatory requirements
2. SCOPE:
The procedure covers Blister, Packaging, Sterilization and Distribution of the

medical devices
3. DEFINITIONS AND ABBREVIATIONS:
I V – Intravenous- existing or taking place within, or administered into, a vein or

veins.
Sterilization: the process of making something free from bacteria or other living
microorganisms
Cannula- a thin tube inserted into a vein or body cavity to administer medication,
drain off fluid, or insert a surgical instrument.
4. RESPONSIBILITIES:
Production operator has the responsibility of carrying out the procedure as

prescribed.
Production Supervisor has the responsibility of ensuring that the procedure is

executed as per the requirements.
Production Manager has overall responsibility for effective implementation of this

procedure.
5. FLOWCHART:
PRODUCTION PROCESS FLOW CHART OF
I.V. CANNULA
Requisition of I.V. CANNULA
& packing Material etc.
I.V. Cannula &

Primary packaging
Batch Stamping
Accepted Rejected
Secondary Packing
Dispose
Tertiary/Box
packing
Bio-Burden
EO Gas
Sterilization
Microbiological
Quarantine
Tests (Sterility test)
Sterility test Report
Accepted Non Accepted
Send to Finished
Goods Store
6. PROCEDURE DESCRIPTION:
Blister / Packing
 Pack the device singularly in a hard blister film and a medical grade paper.
 At the packing area, pack in a secondary package of either 100 or 50 pieces.
 Finally pack into tertiary containers which are sealed ready or sterilization
Sterilization and Distribution
 Ensure you have Ethylene Oxide gas and carbon dioxide in the ration of 20:80.
 Stack the products on pallets in the quarantine area for 14days pending sterility
test.
(N/B Sterility of the device is vital)
 Ensure stringent measures are taken assure they are free from disease-causing
agents.
 After they pass the quality checks, release to the finished goods store for sale.
7. Quality Control
The quality of the components of these devices is checked during each phase of
manufacture. Consequently, Quality inspectors randomly check components at fixed time
intervals to ensure they meet size, shape, and consistency specifications. These random
samples give a good indication of the quality of the intravenous cannula produced. Visual
inspection is the primary test method. However, more rigorous measurements should also
be performed. Measuring equipment such as Vanier caliper, weighing scales, leakage
test machines, micro pipette, a micrometer should be used to check the length, width,
and thickness of the component pieces., Quality inspectors should be stationed at various
points of the production process and visually inspect the components as they are made.
Examples of nonconformities to check are: deformed IV Cannula components, leakage,
black spots, pieces that fit together incorrectly, or inappropriate packaging
8. ENVIRONMENTAL:
Intravenous cannula material wastes are non bio-degradable wastes and should be
disposed appropriately to ensure no negative effect on the environment.
9. OCCUPATIONAL HEALTH AND SAFETY:
. Proper training as well as awareness should be created to the person handling the
equipment. Safety signage is also good to portray for the safety of the operators running
the production equipment.
10. TRAINING:
To avoid contamination of devices great should be done to all associates involved in

implementing this procedure.
11. PREVENTIVE AND CORRECTIVE ACTION:
Incase this procedure is not successful or the expected results are not achieved then the
failure should be addressed through a corrective action approach as per the corrective
action procedure.
12. RECORD KEEPING:
Record (Title) Form No. Storage Location Retention Period
List of Reviewers:
Production operators
Quality Assurance Manager
Production Manager
Document Approval
Approval Level: CEO HOD X
Approver’s Name Approver’s Signature

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REVITAL HEALTH EPZ LIMITED

INTRAVENOUS CANNULA PROCEDURE

INTRAVENOUS CANNULA PROCEDURE

REVISION REVISE DESCRIPTION DATE

The procedure covers Blister, Packaging, Sterilization and Distribution of the

3. DEFINITIONS AND ABBREVIATIONS:

I V – Intravenous- existing or taking place within, or administered into, a vein or

Production operator has the responsibility of carrying out the procedure as

Production Supervisor has the responsibility of ensuring that the procedure is

Production Manager has overall responsibility for effective implementation of this

I.V. Cannula &

Sterility test Report

Accepted Non Accepted

Sterilization and Distribution

9. OCCUPATIONAL HEALTH AND SAFETY:

To avoid contamination of devices great should be done to all associates involved in

12. RECORD KEEPING:

Record (Title) Form No. Storage Location Retention Period

Approval Level: CEO HOD X

Approver’s Name Approver’s Signature

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