APR January/February 2022 - 25

« INTERVIEW
Photo courtesy of Vanrx showing the Vanrx Microcell Vial Filler installed at Eurofins BioPharma Product Testing's San Diego facility
Our state-of-the-art vial filler is capable of handling multiple sizes of
vials and producing multiple batches of various drug products on a
single machine, thereby providing maximum flexibility to clients.
The system utilizes pre-washed, depyrogenated, ready-to-use, sterile
vials that at are nested in sets for rapid filling. The vial system allows
for less moving parts, reducing the risk of downtime due to a broken
conveyer system.
Because the system's flow path from sterile bulk to the fill needle is
100% disposable, product never touches the fill equipment. As a result,
we are able to switch support to different product types with multiple
batches very quickly. The isolator environment, with vapor hydrogen
peroxide decontamination, requires less cleaning time and the highest
level of cleanliness.
What types of drug products are best suited
for this type of sterile filling system?
While we can support large and small molecule products, including
biologics, such as antibody solutions, gene therapy products, etc., our
system is ideally suited for high value products with minimum product
hold-up in the low-volume fill line and right-sized surge bags; nondestructive
weight checks conserve vials.
It is ideal for personalized medicines (either multiple treatment variants
or autologous treatments). Eurofins offers the agility to support these
with the potential to make multiple batches of personalized medicines
each day.
The system is also adaptable to BSL2 filling for gene therapy and
biologic products needing additional isolation not provided by
traditional filling lines.
Can you describe the clean room classification
required, and walk us through the sterile fill
finishing process?
The Microcell Filler is an ISO-5 isolator that is set up in an ISO-8, Grade
A clean room with HEPA filtration and laminar flows. The room is
designed to be unidirectional with drug substance materials coming in
one door and finished product out another.
As needed, the drug substance is concentrated and compounded in
this suite. Once the bulk formulation is complete (pre-filtration samples
may be taken), it is moved into the ISO-5 hood where it is sterile filtered
through dual filters using a peristaltic pump into a 5-liter bag with
aseptic connectors. From this point forward, the product is in a sealed
environment. The bag may be sampled through a medicine port if post
www.americanpharmaceuticalreview.com |
| 25
»
http://www.americanpharmaceuticalreview.com

APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022

APR January/February 2022 - Cover1
APR January/February 2022 - Cover2
APR January/February 2022 - 1
APR January/February 2022 - 2
APR January/February 2022 - 3
APR January/February 2022 - 4
APR January/February 2022 - 5
APR January/February 2022 - 6
APR January/February 2022 - 7
APR January/February 2022 - 8
APR January/February 2022 - 9
APR January/February 2022 - 10
APR January/February 2022 - 11
APR January/February 2022 - 12
APR January/February 2022 - 13
APR January/February 2022 - 14
APR January/February 2022 - 15
APR January/February 2022 - 16
APR January/February 2022 - 17
APR January/February 2022 - 18
APR January/February 2022 - 19
APR January/February 2022 - 20
APR January/February 2022 - 21
APR January/February 2022 - 22
APR January/February 2022 - 23
APR January/February 2022 - 24
APR January/February 2022 - 25
APR January/February 2022 - 26
APR January/February 2022 - 27
APR January/February 2022 - 28
APR January/February 2022 - 29
APR January/February 2022 - 30
APR January/February 2022 - 31
APR January/February 2022 - 32
APR January/February 2022 - 33
APR January/February 2022 - 34
APR January/February 2022 - 35
APR January/February 2022 - 36
APR January/February 2022 - 37
APR January/February 2022 - 38
APR January/February 2022 - 39
APR January/February 2022 - 40
APR January/February 2022 - 41
APR January/February 2022 - 42
APR January/February 2022 - 43
APR January/February 2022 - 44
APR January/February 2022 - 45
APR January/February 2022 - 46
APR January/February 2022 - 47
APR January/February 2022 - 48
APR January/February 2022 - 49
APR January/February 2022 - 50
APR January/February 2022 - 51
APR January/February 2022 - 52
APR January/February 2022 - 53
APR January/February 2022 - 54
APR January/February 2022 - 55
APR January/February 2022 - 56
APR January/February 2022 - 57
APR January/February 2022 - 58
APR January/February 2022 - 59
APR January/February 2022 - 60
APR January/February 2022 - 61
APR January/February 2022 - 62
APR January/February 2022 - 63
APR January/February 2022 - 64
APR January/February 2022 - 65
APR January/February 2022 - 66
APR January/February 2022 - 67
APR January/February 2022 - 68
APR January/February 2022 - 69
APR January/February 2022 - 70
APR January/February 2022 - 71
APR January/February 2022 - 72
APR January/February 2022 - 73
APR January/February 2022 - 74
APR January/February 2022 - 75
APR January/February 2022 - 76
APR January/February 2022 - 77
APR January/February 2022 - 78
APR January/February 2022 - 79
APR January/February 2022 - 80
APR January/February 2022 - 81
APR January/February 2022 - 82
APR January/February 2022 - 83
APR January/February 2022 - 84
APR January/February 2022 - Cover3
APR January/February 2022 - Cover4
https://www.nxtbookmedia.com