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- What is the difference between the term "aseptic"
and the term "sterile" as it relates to connections?
By Webster's definition, the terms are synonymous, meaning free
from microorganisms. By application, we use the term "aseptic"
to describe a process or technique that is designed to prevent
the access of microorganisms and the term "sterile"
to refer to a validated process or technique that has successfully
passed a microbial challenge with the appropriate indicator organism
at the appropriate concentration of Colony Forming Units (CFU).
The sterility assurance level of most sterilization technologies,
Gamma, E-beam, ETO, Autoclave, is 1x106 CFU; that is, the biological
indicator strips of each indicator organism has that level of
bacteria loading.
The above discussion relates to connections in the following way:
processes, devices or techniques that are not or cannot be appropriately
or reasonably challenged using a microbial agent are considered
"aseptic." Open connections that take place in a clean
room or at a clean bench usually fall into this category. Processes,
devices, or techniques that can be challenged using an appropriate
microbial agent can usually be described as "sterile"
after successfully passing the challenge. A validated process
based on the BioQuate Disposable Aseptic Connector (DAC) would
fall into this category.
- How did BioQuate challenge the Disposable Aseptic Connector
(DAC)?
The microbiological challenge to the DAC consisted of a direct
inoculation to the exposed surfaces of the DAC and then proceeding
to the connection of two DACs. The specifics on the challenge
level, the protocol and the results can be obtained from BioQuate,
Inc.
- What procedure does BioQuate recommend for customer-based
(microbial) validation of the DAC?
The DAC customer has many options in regards to validation of
the DAC. Noted below are two approaches.
Options:
- Follow the BioQuate Validation Protocol.
- Develop an in-house protocol, specific to the customer.
Information to support option 1 can be obtained from BioQuate
in terms of a written protocol, test data from an independent
laboratory, and assistance in vendor selection for components.
Option 2 should be carefully evaluated by the customer and discussed
with a BioQuate representative before committing to this approach
in order to assure a proper challenge to the DAC. Specific information,
including vendors, is contained in the document titled "Validation
Information" that is available from the BioQuate Web site.
- Is there any adhesive in contact with the fluid path or
any of the fluid path components?
No. By design, there is no adhesive in contact, directly or indirectly,
with the fluid path. The polyester film that covers the silicone
gasket and the fluid path is free of adhesive on the face that
contacts the gasket and the fluid path.
- What are the materials that make up the fluid path?
The molded body of the DAC is made of a USP Class VI grade of
polycarbonate and the gasket that creates the fluid tight seal
is composed of silicone rubber, USP Class VI. Non-fluid path components
are healthcare grade materials, where available.
- Is it necessary to use a sanitary clamp even in a low-pressure
application?
Yes. The sanitary clamp compresses the silicone gaskets of each
DAC together and creates a fluid tight seal. Without the sanitary
clamp, there is not sufficient pressure for the connection to
be fluid-tight.
- If I make a mistake in the connection process, can I open
the latches up and start again? Is there a recommended recovery
process for mistakes?
Once the DAC connection is made, the union cannot be opened without
compromising the sterility of the connection. It is recommended
that a DAC "Y" assembly be inserted in the tubing manifold
as a safety access port to allow for recovery from situations
that require isolation of a particular manifold section. Also,
the release paper covering the adhesive face of the DAC is designed
so that engagement of two DACs is very difficult to accomplish
without prior removal of the release paper. This was done to prevent
two DACs from being latched before the release paper was removed
since the mechanical latches are also, designed to be non-opening.
- What is "open connectivity"?
The term "open connectivity" refers to the connection
flexibility of the BioQuate DAC system. Specifically, the DAC
is genderless (no male/female connections) and standard in connection
size; therefore, regardless of the barb (tubing) size on the DAC
the operator is assured that any size DAC, will connect with any
other DAC. Since the DAC will be available in barb (tubing) sizes
from ¼" up to ¾", the DAC system can function
as the supply line, the distribution (bag) line and the sample
bag line without connection difficulties.
- What is a "dry to dry" connection?
The phrase "dry to dry" connection refers to the required
condition of each DAC prior to connection. The DAC must be kept
free of fluid within the tubing through the use of a tubing clamp
until the connection is completed and a sanitary clamp is in place.
- What is the recommended sterilization method for the DAC?
The DAC is designed for sterilization by E-beam or Gamma radiation.
- What is meant by the term "closed system" as it
relates to the DAC?
The phrase "closed system" refers to the continuity
of contact between the sealing gaskets of the fluid path during
the process of connection and the removal of the rolling membrane.
This technology maintains the sterility of the fluid path and
virtually eliminates the potential for contamination.
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