BALLYA Diagnostics for IVD Research & Develop
How to manufacture pregnant test?
Jason, October 8, 2020

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Pregnant test is a home pregnancy test, it can be detected less than 5 minutes to get accuracy results without to see a dotor. The hcg test is very popular rapid test in the world because it’s easy to use, low production cost, high demand and high accuracy result. There are thousands brands of hcg test in the world. Do you want to have your own brand for pregnant test? Here are some tips for you.

  1. Create a new brand for IVD product
  2. Set up a medical company
  3. Register your brand and medical company in local health department or Food and Drug Administration
  4. Find a reliable in vitro diagnostics manufacturer to supply pregnant test
  5. Contact distributors and sell products

After preparation, you can manufacture pregnant test by yourself or purchase semi product or the end product.

Type of pregnant test

Strip format of hcg test

Strip format of hcg test
Strip format of hcg test

Cassette format of hcg test

Cassette format of hcg test
Cassette format of hcg test

Parameter of pregnant test

Sensitivity: 25mIU/ml (other sensitivity customized)
Detection specimen: Urine, Serum
Strip dimension: width 2.9mm, 3.9mm; length 6 - 8cm

How to manufacture pregnant test?

Here is a manual production, all procedures must be under GMP factory or clean room with temperature & humidity controled.

The uncut sheet of pregnant test
Dimension: 250 x 60 mm; 250 x 70 mm; 250 x 80 mm;

take a pregnancy test
take-a-pregnancy-test
tests for pregnancy
tests-for-pregnancy

Cut the hcg test uncut sheet into strip format

pregnancy test
pregnancy test

Load the strip into cassette

pregnancy tests
pregnancy tests

Cassette format selection for pregnant test
Normal dimension: 60 x 3 mm, 60 x 4 mm

positive pregnancy test
positive pregnancy test
pregnancy test positive
pregnancy test positive
pregnancy test at home
pregnancy test at home

Components for pregnant test

micropipette
micropipette
desiccant
desiccant
pregnancy testing
pregnancy testing

Packing pregnant test with foil pouch

test pregnant
test pregnant

Coding procedure for pregnant test
Use Inkjet printer to code the product name, production date, expiry date, batch number on foil pouch.

inkjet printer
inkjet printer

Final packing into box of pregnant test

when to take pregnancy test
when to take pregnancy test

How to pack pregnant test automted?

Use the Pregnant Test Packaging Machine (IVD rapid test packaging machine), from uncut sheet cuting to strip pack into foil pouch, it’s full automated system. The max capacity upto 2500 pouched per hour per system.
The procedures of pregnant test automated packaging as below

  1. Loading the uncut sheet of pregnant test
  2. Cutting the sheet into pregnant test strip
  3. Loading the cassette case(bottom & cover) of pregnant test
  4. Transport cassette case and pregnant test strips
  5. Scan and remove the unquality pregnant test strips
  6. Loading pregnant test strip into cassette case
  7. Compress the cassette case
  8. Loading the pregnant test strip, desiccant, mini pipette into the foil pouch
pregnant test packaging machine
pregnant test packaging machine

Conclusion

It’s not difficult to produce pregnant test. While control the production’s environment, it will be easy to manufacture a good quality hcg test. According to the sales volume to select manual product or automated manufacturing system. The IVD rapid test automated packaging machine is not only for pregnant test, also for other type IVD product.

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