42 Pharmaceutical Technology BIOLOGICS AND STERILE DRUG MANUFACTURING 2020 P h a r mTe c h . c o m
Operations
'Restricted Access Barrier Systems (RABS) and iso-
lators are beneficial in assuring the required condi-
tions and minimizing the microbial contamina-
tion associated with direct human interventionsin
the critical zone. Their use should be considered
in the CCS. Any alternative approaches to the
use of RABS or isolators should be justified' (1).
Still RABS do provide access for the personnel to
aseptic critical operations, and therefore, the risk
of contamination is reduced but not to a level as
isolators provide. Isolators are a physical barrier to
the personnel and they get only access to the inside
of the isolator through the isolator gloves.
Single-use systems
PharmTech: How have single-use systems improved
the sterility of biopharmaceutical products?
Denk (SKAN): Single-use and the proof of sterile
integrity is still, in some cases, not easy to validate.
For that reason, I can't say if single use [has] im-
proved the sterility. I would say the major reasons
for single-use system are f lexibility, as the single-
use system—like filling kits—are easy to install
and could be changed in design if the process does
require a change; and preventing cross contamina-
tion as you don't clean the single-use system, you
dispose it afterwards. Recent discussion about the
waste of plastic and how this fits in sustainability
needs improvement.
PharmTech: Are there contamination vulnerabil-
ities in single-use systems? If yes, how can they
be prevented?
Denk (SKAN): As mentioned before, the sterile in-
tegrity of single-use system is important as this
poses a risk to the sterile product or sterile compo-
nents used in aseptic processing. Let's have a look
on the transfer of stoppers to the aseptic filling line
located in an isolator. For single-use systems, stop-
per bags are used where the bag is connected with
a rapid-transfer port to the isolator. Although this
single-use system is widely used and accepted for
stoppers to be stored, the integrity of the serility
can't be really tested from the point of packaging
and sterilization to the point of use. An alterna-
tive solution could be a stopper processing system.
In the stopper processing system, the stoppers are
washed, siliconized, and sterilized and transferred
directly to the isolotor filling line.
Reference
1. EC, Annex 1 : Manufacture of Sterile Products, https://ec.europa.
eu/health/sites/health/files/files/gmp/2020_annex1ps_sterile_
medicinal_products_en.pdf
PT
"...the sterile integrity of
single-use system is important
as this poses a risk to the
sterile product or sterile
components used in aseptic
processing."
—Richard Denk, SKAN
Absorption Systems LLC ......................................................................... 39
Emergent Biosolutions ............................................................................ 5
Gemü Valves ..............................................................................................11
International Centre for Diffraction Data ............................................... 23
Mission Pharmacal Company ................................................................. 15
Pfanstiehl .................................................................................................. 17
Renishaw ................................................................................................... 29
Tergus Pharma ......................................................................................... 31
Veltek Associates, Inc .............................................................................. 3
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