APR Sept/Oct 2023 - 49

» EDITOR'S TOP TECH
Absorbance Microplate Reader
The Nebula® Absorbance Reader is a new microplate
reader for streamlined endotoxin and pyrogen
testing. Similar to the Nebula® Multimode
Reader, the Nebula® Absorbance Reader is designed
for use alongside Lonza reagents. It is
optimized to work with, and meet all the specifications
of, Lonza's absorbance-based endotoxin
assays such as the Lonza PYROGENT® 5000
Turbidimetric and Kinetic-QCL® Chromogenic
Endotoxin Assays. The new reader also supports
the readout for monocyte activation tests (MAT)
such as Lonza's PyroCell® MAT System. The
Nebula® Absorbance Reader provides QC labs
with new and improved functionality. It features
high-performance optics and monochromatorbased
wavelength selection to enable precise
and accurate measurements of endotoxin levels.
Its compact design requires minimal laboratory
space and allows for workflow flexibility.
The reader is fully integrated with the latest version
of Lonza's WinKQCL® Endotoxin Detection
and Analysis Software (v6.4), enabling users to
meet the latest data integrity requirements. This
reduces training burdens by removing the need
for existing WinKQCL® Software users to learn
new software in order to use the new reader.
Lonza
www.lonza.com/absorbance-nebula
Anti-Counterfeiting Technology
Clear Code is a pre-treatment or coating applied
to cartons and labels that enables precise
patterns to be applied to the substrate using
CO2, Fibre, or YAG laser energy. This results in
high contrast secure coding for pharma packaging
that avoids the need to directly inscribe
information by instead using bespoke colour
changing technology.This next-generation coding
system produces codes that are completely
scuff and smudge resistant and are not susceptible
to environmental degradation. Clear
Code eliminates the problem of dust particles in
packaging lines caused by abrasion - producing
safer working conditions - while also ensuring
Clear Code has the widest substrate compatibility
in the industry.
MM Packaging
www.mm-packaging.com
The TPR 25 Pilot mobile tablet coater features all
inlet and exhaust airflow systems required for
the coating process integrated into this compact
pilot-scale unit for simple plug and play
commissioning. As a modern all-in-one solution,
its applications cover everything from development
activities and scale-ups to the production
of very small batches. The pilot coater is
designed to handle batches weighing anything
from 1 to 25 kg, making it suited for an extremely
wide batch size range from 5 to 100 percent.
The coating pan's enormous flexibility is made
possible by fully automated processes requiring
no manual adjustments. The TPR 25 Pilot
is equipped with Tecpharm's patented Optima
spray arm, which is controlled by a sonar system
that automatically adjusts the distance between
the spray gun and the tablet bed. Thanks to the
spray arm's intelligence, the coater does not
have to be stopped and opened to correct the
spray distance while the process is running.
Romaco Group
www.romaco.com
www.americanpharmaceuticalreview.com |
| 49
GMP Software Features Advanced
Process Optimization Capabilities
Company has released a software package
designed to expand the use of the SamuxMP
and SamuxMP Auto mass photometers in GMPregulated
environments. The SamuxMP range is
optimized for AAV analytics and provides rapid
and accurate measurements of empty:full AAV
ratios with minimal sample required. The new
software now enables the implementation
of mass photometry within AAV-based gene
therapy manufacturing facilities while adhering
to the strict
regulatory requirements of
FDA 21 CFR 11 and EMA Annex 11. The newly
launched software package includes three different
applications: AcquireMP, EvaluateMP, and
ManageMP. These applications offer user access
control, audit trails, standardized workflows,
and electronic signatures for streamlined and
controlled AAV analytics in manufacturing environments.
This provides compliance to regulations
around data traceability and integrity during
acquisition, analysis, and export.
Refeyn
www.refeyn.com
Pilot Tablet Coater
»
http://www.refeyn.com http://www.lonza.com/absorbance-nebula http://www.mm-packaging.com http://www.romaco.com http://www.americanpharmaceuticalreview.com
APR Sept/Oct 2023

Table of Contents for the Digital Edition of APR Sept/Oct 2023
