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In many manufacturing industries 100% testing of products is not necessary, sampling a quantity from each batch for SPC analysis is quite acceptable, however, in medical component manufacturing where an out of specification component could cost someone's life, 100% testing is definitely required.
Most components are produced in high volume, which can lead to problems involving test time, also many components are made from moulded plastic for cost reasons because they are for one time use only.
All of which means that the testing equipment must be reliable, fast and cost effective when used 24 hours a day, 365 days a year!
Air-gauging has proved remarkably successful for this purpose. Page 2 >>
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1) Checking for blockage due to plastic flashing:
A large manufacturer of moulded medical plastic parts needed to check 100% of its production of intubator tubes for minimal plastic flashing blockage - the tubes are used to keep the airway open by insertion into the patient's throat.
We looked at the fast test time and the amount of blockage allowable and decided that a very low pressure precision regulator together with an air flowmeter, pass & fail lights and signalling outputs would be adequate.
In this case a nice simple solution has proved to be the best, most cost effective solution for the customer.
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2) Monitoring a patient's assisted breathing treatment:
Research doctors, formerly at Brompton hospital, required an instrument to monitor young (premature to 3 years old) patients' assisted breathing by an intermittent negative exothoracic pressure applied via an incubator as well as the positive pressure applied by a face mask, which would give an alarm if pre-set limits were exceeded or the mains supply failed.
We listened closely to what the doctors required and designed a single instrument which did what they wanted. Almost 100 units have been made for use in the trial of this new treatment in hospitals worldwide so far. As the safety aspect is paramount we manufacture and test each one in-house.
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3) Air-gauging solutions to other medical component testing problems:
* Testing for correct needle size and non-blocked flow through manufactured plastic wing type of needle sets with Luer fittings.
* Testing needle sets for drip feed use with bag feed attachment, roller adjustments, sight glass and filter, over pressure actuator and Luer fittings.
* Testing high performance in-line filters and syringe filters for correct filter material characteristics.
* Checking plastic moulding hole sizes in inhalator drug delivery systems to give correct doses.
Plus many other applications. All of these tests were needed at high speed.
Please note we are not medically trained so some of the above terms and descriptions may not be medically correct!
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March Designs & Measurements
Unit 11, Alfred Street
Dunstable
Beds LU5 4HZ England
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