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Our facilities include an ISO 9000-2000 laboratory as well as our dedicated ageing oven and sophisticated leak testing equipment. Our engineers bring extensive experience and knowledge of medical device development and testing.
Shelf Life - Accelerated Ageing 
(PDF printer version)
- Accelerated ageing according to ASTM F1980. Storage of packs at elevated
temperature is used to simulate shelf life ageing in a shorter time period. Suitable
for porous and non-porous packs.
Seal Integrity
(PDF printer version)
- External visual inspection according to ASTM F1886-98 (2004).
A relatively simple test, we normally use it to supplement information gleaned
from other seal tests
- Bubble emission according to ASTM D3078, vacuum test for non-permeable
packs.
- Dye penetration according to ASTM F1929 where dye is injected
into sealed packs. Vacuum is applied and ingress into seals is then inspected
visually. Suitable for packs with at least one transparent web.
- Hospital environment microbial aerosol test. This test has been validated
internally and shown to find channels as small as 0.3mm (no attempt has been made
to validate below this). It simulates 1 year of storage unprotected on a hospital
trolley.
- Liquid immersion test - requires sterile packs.
- Calibrated hole test. In this standard perforation test, impermeable
packs are fitted with laser drilled holes of 12.5, 25, or 50 micron diameter.
Leaking from the packs is then measured using a vacuum decay method and compared
to non-perforated packs. We use this test for validation and IQ / PQ studies on
customers' own machines.
Seal Strength
- Burst test according to ASTM 1140-00. A good strength test that
tests the entire seal area, locating the weakest point. Suitable for both porous
and non-porous packs.
- Seal tensile peel test to ASTM F88.
Web Materials
- ASTM F1608 - Microbial ranking of porous packaging materials. This
test evaluates the effectiveness of web materials as a barrier.
- Dust drum microbial test for whole packages, as developed by HIMA.
Shipping
(PDF printer version)
Uniform shipping simulation test according to ASTM or ISTA.
- Random vibration
- Vehicle stacking
- Compression
Pre Conditioning Options
- Tropical - temperature 38°C - relative humidity 85%
- Desert - temperature 50°C - relative humidity low
- Frozen - temperature minus 20°C - relative humidity low
- Ambient / wet - temperature 23°C - relative humidity 85%
Please E-mail:
or phone 08454 588924 for a confidential discussion about your project or product.
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