Aseptic sampling is the process of
aseptically withdrawing materials used in
biopharmaceutical
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, t ...
processes for analysis so as not contaminate or alter the sample or the source of the sample.
[ASTM E1287-89(1999) "Standard Practice for Aseptic Sampling of Biological Materials," ASTM International, West Conshohocken, PA, 1999, DOI: 10.1520/E1287-89R99, www.astm.org] Aseptic samples are drawn throughout the entire biopharmaceutical process (
cell culture
Cell culture or tissue culture is the process by which cells are grown under controlled conditions, generally outside of their natural environment. The term "tissue culture" was coined by American pathologist Montrose Thomas Burrows. This te ...
/fermentation,
buffer
Buffer may refer to:
Science
* Buffer gas, an inert or nonflammable gas
* Buffer solution, a solution used to prevent changes in pH
* Buffering agent, the weak acid or base in a buffer solution
* Lysis buffer, in cell biology
* Metal ion buffer
* ...
&
media
Media may refer to:
Communication
* Media (communication), tools used to deliver information or data
** Advertising media, various media, content, buying and placement for advertising
** Broadcast media, communications delivered over mass el ...
prep,
purification, final fill and finish
[Stockdale, D. Overview of Aseptic Fill/Finish Manufacturing. Am. Pharm. Rev. 2004.]). Analysis of the sample includes sterility, cell count/cell viability, metabolites, gases, osmolality and more.
Aseptic sampling techniques
Biopharmaceutical drug manufacturers widely use aseptic sampling device
to enhance
aseptic technique
Asepsis is the state of being free from disease-causing micro-organisms (such as pathogenic bacteria, viruses, pathogenic fungi, and parasites). There are two categories of asepsis: medical and surgical. The modern day notion of asepsis is deriv ...
. The latest innovations of sampling devices harmonize with emerging trends in disposabilit
enhance operating efficiencies and improve operator safety.
Turn-key aseptic sampling devices
Turn-key Aseptic Sampling Devices are ready-to-use sampling devices that require little or no equipment preparation by the users. Turn-key devices help managers reduce labor costs, estimated to represent 75% to 80% of the cost of running a biotech facility.
Turn-key aseptic sampling devices include:
# A means to connect the device to the bioprocess equipment
# A mechanism to
aseptically access the materials held in the biopress equipment
# A means to
aseptically transfer the sample out of the bioprocess equipment
# A vessel or container to
aseptically collect the sample
# A mechanism to
aseptically disconnect the collection vessel
To protect the integrity of the sample and to ensure it is truly representative of the time the sample is taken, the sampling pathway should be fully contained and independent of other sampling pathways.
Cannula(needle) based aseptic sampling devices
In a cannula-based aseptic sampling system, a needle penetrates an elastomeric septum. The septum is in direct contact with the liquid so that the liquid flows out of the equipment through the needle. Iterations of this technique are used in medical device industries but don't usually include equipment combining the needle and the septu
Introducing a potentially non-sterile needle into the bioprocessing equipment violates good aseptic technique. With a cannula based aseptic sampling devic
the needle and septa are combined into a
Hermetic seal, hermetically sealed aseptic sampling device.
References
Biological techniques and tools