Apligraf® Storage FAQs
1.
Do I need to record the Apligraf temperature at the time of Apligraf receipt?
The Joint Commission (TJC, formerly JCAHO) Transplant Safety Standard TS.03.01.01
specifies that if the distributor uses validated shipping containers, the receiver may document
that the shipping container was received undamaged and within the stated time frame.
Apligraf is shipped in a validated shipper/storage box that has been approved by the FDA;
therefore, TJC does not require Apligraf temperature to be verified upon receipt.
2.
The Phase Change Material (PCM) packs were received frozen. Is Apligraf
OK to use?
The receipt of a “frozen” or “solidified” PCM should not preclude the use of Apligraf. The PCM
packs within the validated, specially designed shipper efficiently absorb and release heat in
response to fluctuations in ambient temperature. During shipment, the ambient temperature
may fall causing the PCM packs to solidify. The PCM packs are designed to solidify at
ambient temperatures below 68°F (20°C).
As a reminder, the Apligraf Package Insert instructions must be followed by the user facility;
when followed, the product is acceptable for clinical use. The product should be inspected
upon receipt to assess the pH of the agarose gel medium using the color coded pH card
included in the validated shipper/storage box. At this time the expiration date and integrity of
the sealed heavy gauge polyethylene pouch (polybag) should be assessed and then the
Apligraf should be returned to the validated shipper/storage box and stored under controlled
room temperature 68°F - 73°F (20°C - 23°C) up to 15 minutes prior to use.
3.
How should Apligraf be stored?
Per the Apligraf Prescribing Information, Apligraf must be kept in its sealed and labeled heavy
gauge polyethylene pouch (polybag) under controlled room temperature 68°F - 73°F (20°C 23°C) until use. Apligraf is supplied in a shipper/storage box that is designed to minimize
temperature fluctuations when it is properly closed. A validation study reviewed by the FDA
demonstrated that the shipper/storage box maintains product stability despite exposure to
transient temperature extremes such as those experienced during product shipment. Apligraf
must be stored in this box until the time of use. Apligraf should not be refrigerated, incubated,
or stored outside of the box. Apligraf is not subject to humidity storage requirements.
Organogenesis recommends that the Apligraf unit be inspected upon receipt, as well as just
prior to use.
 The agarose in the Apligraf package contains a pH sensitive color indicator.
Compare the color of the agarose with the provided pH color chart to confirm that the
pH of the unit is within the acceptable range of 6.8-7.7.
 There should be no evidence of contamination, visible particulates, or pungent odor.
 Once inspected, the unit should be returned to the original shipper/storage box and
stored under controlled room temperature 68°F - 73°F (20°C - 23°C) until use.
 It is important to repackage the unit within the shipper/storage box exactly as
received and tape the box closed.
NPRC 2011-043
NRPC approved October 26, 2011, updated February 12, 2015
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Apligraf® Storage FAQs
4.
Can Apligraf be stored outside of the shipper/storage box, at facilities that
lack storage space, or do not permit corrugated cardboard?
Per the Apligraf Prescribing Information, Apligraf must be kept in its sealed and labeled heavy
gauge polyethylene pouch (polybag) under controlled room temperature 68°F - 73°F (20°C 23°C) until use. In order to meet this requirement, Apligraf must be stored within the closed,
validated shipper/storage box in a room with the thermostat set at 68°F - 73°F (20°C - 23°C).
If cardboard is not permitted in the clinical area, a suggested solution is to place the entire
shipper/storage box, including the outer cardboard, into a large plastic container covered with
a lid. If your facility is unable to accommodate the shipper/storage box and has an incubator
or ambient temperature chamber set at 68°F - 73°F (20°C - 23°C), the sealed and labeled
polybag containing Apligraf may be removed from the box and stored within this chamber. It
is important that the storage chamber be appropriately monitored to ensure that the storage
conditions remain at 68°F - 73°F (20°C - 23°C).
5.
Do I need to monitor the Apligraf temperature?
The Joint Commission (TJC, formerly JCAHO) Transplant Safety Standard TS.03.01.01
specifies it is required that the room temperature be recorded at least once daily for tissue
products stored at controlled room temperature. Continuous temperature monitoring and
alarm systems are not required. A once-a-day log of the temperature of the room in which
Apligraf is stored, using an accurate thermometer, is usually considered sufficient.
6.
Apligraf was stored at greater than 73°F (or less than 68°F). Is Apligraf
OK to use?
If the average daily (24-hour) storage temperature in the room is outside of the range of 68°F
- 73°F (20°C - 23°C), the product should not be used. The shipper/storage box can withstand
temporary ambient temperature shifts, such as during transport and storage at customer
sites, while maintaining sufficient control over its internal temperature to ensure product
stability. This was demonstrated in an FDA approved validation study. The shipper/storage
box was tested at temperatures ranging from 14°F - 104°F (-10°C - +40°C), with each
temperature maintained for an approximately 4 hour interval, over a 24-hour period. Despite
these temporary fluctuations in ambient temperature, the Apligraf shelf life was maintained.
7.
What is the Apligraf shelf-life?
The FDA-approved shelf-life of Apligraf is 15 days from the packaging date, when stored within the
closed shipper/storage box at a controlled room temperature 68°F - 73°F (20°C - 23°C) until use.
Each unit of Apligraf is labeled with an expiration date, which is 15 days from the packaging date.
8.
What is the Apligraf expiration date?
The expiration date of Apligraf is indicated on the labeled heavy gauge polyethylene pouch
(polybag) that contains Apligraf. Apligraf must not be used after 11:59 PM ET on the date of
expiration. The expiration date is 15 days from the packaging date. Per the Apligraf
Prescribing Information, do not open or use Apligraf after the expiration date.
9.
Who can I contact for more information on Apligraf storage conditions?
Contact the Organogenesis Medical Information Center at 1-888-432-5232 Option 6 or via
email at MedInfo@organo.com.
NPRC 2011-043
NRPC approved October 26, 2011, updated February 12, 2015
P a g e |2