Collection and processing are
undertaken by trained employees
ensuring compliance with cGMP
procedures in USDA inspected
abattoirs and our FDA licensed
manufacturing facility. No
additives are used and
temperatures are carefully
monitored at all times. Fetal
Bovine Serum is collected
aseptically by cardiac puncture
closed system. Standing donor
herds are bled by aseptic venous
puncture closed system. After
collection the blood is
refrigerated and within 24 hours
the clotted blood undergoes
refrigerated centrifugation.
Prior to final pooling, each 3.5
L jug is subjected to numerous
tests to ensure compliance with
raw product specifications. Each
is tested for: Endotoxin, pH,
Osmolality, Protein and
Hemoglobin. Approved serum is
pooled in a 1000 L refrigerated
tank prior to filtration, to
facilitate pool uniformity.
Fetal bovine serum is triple
0.1µ filtered in a validated
class 100 environment in our new
class 10,000 clean room and
aseptically filtered into
pre-sterilized PETG bottles. The
finished product is then quick
frozen at or below -20° C.
Tissue Culture Biologicals is
dedicated to providing products
of the highest quality. Our
products are carefully
controlled, tested and
documented through all stages
from receiving to release in
compliance with the Code of
Federal Regulations title 21,
part 820, and title 9, USDA:
Animals and Animal Products.
Tissue Culture Biologicals
maintains complete documentation
for all lots of products and
uses detailed manufacturing
procedures to provide
reproducible processing. We use
only cGMP qualified outside
testing facilities.
Complete Manufacturing Operating
Procedures and Standard
Operating Procedures (MOP/SOP),
are available for inspection
upon request by qualified
customers.
Tissue Culture Biologicals
encourages customers to audit
our manufacturing facility in
Tulare.
Shipping & receiving
All frozen materials are shipped
via overnight carriers. Packed
in an adequate supply of dry ice
to remain frozen until receipt
unless otherwise specified by
the purchaser. Truck shipments
are handled by experienced,
refrigerated carriers and will
be kept frozen until delivered.
Our guarantee cannot extend to
the performance of all delivery
companies and common carriers
but we will replace and
re-deliver any product that does
not meet with customer approval
for any reason.
International
Our shipping rates are for the
United States and its
possessions. Call Customer
Service for rates on
international shipping. All
catalog prices and shipping
rates are quoted in U.S. funds
and do not include applicable
duty, customs charges, or taxes
which are paid by customer. TCB
is approved to ship serum
products to Europe under permit
EU #CA TEC 0013.
Receiving
All serum shipments should
arrive frozen. If delays or
unforeseen circumstances cause
an order to arrive partially
frozen, follow these simple
instructions:
1. Allow
the serum to thaw completely. A
37°C water bath is preferred.
2. Gently swirl or shake the
serum occasionally to assure a
balance of salt to protein
ingredient. Avoid vigorous
shaking causing foaming.
3. Refreeze rapidly. Avoid
repeated freezing/thawing.
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