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We are packaging
consultants with extensive know-how in the development, processing, and
evaluation of form-fill-seal packaging blister trays, laminated and paper
products. We have worked with low and high profile pouches and trays
containing plastic, glass and metal components. These include catheters,
drains, blades, sutures, blood collection tubes, needles and syringes,
canisters, bacteria membrane filters, water and saline cups, sterile
injectables, lyophilized products, towels, gloves, and implantable hemostat
products.
We have established
several test methodologies for the evaluation of seal strength, packaging
integrity, barrier properties, and product stability/self-life. We
have worked with tyvek, polyethylene, polypropylene, polystyrene,
polycarbonate, polyester, polyvinylidene, foil, aluminum, paper, laminates
of, and related top and bottom web materials.
We have resolved
various manufacturing process and product performance and/or quality
problems that include: poor feeding, tracking and processing of web
material; seals with channels, rinkles or no sealing; unacceptable,
non-uniform product seals; contamination of the sealing area; holes in
package; non-uniform applied pressure and temperature of sealing dies to
the web material; mis-alignment, non-optimized draw temperature, pressure
and cycle of top and bottom form/fill/seal dies.
We have worked with laboratory
and manufacturing equipment in the US, UK, Mexico and Puerto Rico that
include: Botolay-Pratt, Mahaffy-Harder, Rotowrap, Instron and others.
Tips for testing package integrity
1.
Establish the air pressure required to break sterility of the package.
Set-up a regulated, compressed air line and attach a needle to it.
Place tape or the equivalent around package are which you will puncture,
then puncture it and record the pressure required to pop it.
2. Establish force
required to peel-apart the package. Make a template with one inch width
cuts; one per each of the four sides. Then use an force gauge, i.e.
instron tester or the equivalent, to record the peel-apart force or seal
strength.
3. Perform ink-dye
test to determine quality of seal. Make solution with blue dye and apply
over the seal area of a package. Then inspect for ink dye leakage through
the package which will be anindication of a wrinkle, no seal, etc. This is
a qualitative test.
4. Perform a black
carbon test. It is basically a test where the package is subjected to a
smoke environment for a period of time and then inspected for any black
carbon that might have entered the package.
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