|
CTS offers a variety of services that are customized to meet eachs clients'
individual requirements.
CUSTOM OVEN CONTROLS
The key to validation is “representative load.” Frequently,
off-the-shelf oven controls are not sufficient for a successful validation.
Ideally, the vials, bottles, and other items should be similar to
or identical to those processed in the oven for production or research
purposes. CTS will make custom oven controls using the same items normally
processed in your oven. Each batch is custom made to demonstrate at least
three-log reduction by your oven, and each batch comes with a Certificate
of Analysis. CTS can also test items after the oven cycle to document
depyrogenation.
Back to Top
CUSTOM REAGENT PRODUCTION
CTS will make small runs of custom reagents. We specialize in endotoxin-free
and glucan-free reagents. Other analyses will be performed as needed.
For information and quotes, please call CTS at 508-540-3444 x2281 or e-mail
testservice@acciusa.com.
Back to Top
METHODS DEVELOPMENT
Some samples and devices are so unique that a method must be developed
to test them for endotoxin. CTS will determine how best to prepare the
sample for testing according to USP <85>, the standard validated
method, or we will develop a method that can be validated using LAL.
Back to Top
METHODS TRANSFER
Many companies have sufficient testing volume to justify performing the
assay in-house. For these customers, Associates of Cape Cod, Inc. supplies
a complete line of the highest quality LAL reagents. CTS supports this
line by working with companies to develop and optimize methods to test
products. CTS also helps customers convert from one methodology to another,
e.g., from testing by the gel-clot method to chromogenic or turbidimetric
assays. The methods developed by CTS are then transferred to the client
for use by their own QC laboratories. Your company gets the assurance
that the method will work well with your products.
Back to Top
|
