APR Sept/Oct 2023 - 116

EQUIPMENT FOCUS
Tube Filler and Vertical Cartoner
The low-cost FP 10 Tube Filler features a
hot air tube heating system for sustainability-minded
energy savings. Its mechanical
design allows excellent accessibility from
all sides, without the type of blockage
sometimes caused by electrical cabinets.
Maximum process reliability is assured via
servo technology, and changeovers can be
performed in under 15 minutes. Capable of
filling and closing up to 70 tubes per minute,
the FP 10 can handle metal, plastic or
laminated tubes. The VI 5 Vertical Cartoner
is an intermittent motion machine with an
open, accessible work area and a modularly
extendable length that optimizes floorspace.
Suitable for a wide array of components
including bottles, tubes, blister packs,
jars, pouches and other similar components,
the touchscreen-operated VI 5 can
produce up to 75 cartons per minute.
IWK
www.iwk.de/en
Robotic Bottle Unscrambler
Automatic robotic unscrambler uses a parallel-kinematic,
multi-axis, pick-and-place
robot module, which separates, orients,
and positions bottles onto a conveyor or
into stabilizing pucks. Unit is ideal for applications
running complex or multiple
bottle shapes, including a broad array of
containers, bottles, tottles, jars, vials, jugs
and tubes. The limited number of changeover
points greatly reduces setup times.
Its integrated hopper minimizes footprint,
and the conveying system is optimized for
robotic handling, with intelligent infeed
metering control reducing recirculation of
bottles. The machine combines speed and
accuracy via the company's dual infeed
system, which purposefully presents two
containers at once to the unit's robotic arms
from a single hopper. This process optimizes
the robotic arms' movements, yielding
throughputs unobtainable by conventional
methods. The setup also minimizes
the machine's overall floorspace footprint.
The machine features a user-friendly 15 "
touchscreen HMI, a sophisticated Rockwell
Automation Optix visualization platform,
and an advanced Allen Bradley integrated
safety programmable logic controller (PLC).
Omega Design Corporation
www.omegadesign.com
116 |
| September/October 2023
Freeze-Light-Protect Label
for Syringes
The Freeze-Light-Protect syringe label combines
light protection with viability at temperatures
well below zero. The new solution is particularly
relevant for sensitive mRNA-based substances
as well as cell and gene therapies. Freeze-LightProtect
securely adheres to the syringe despite
extremely low temperatures, enabling reliable
marking. The specialty label also can be enhanced
with a variety of UV and light protection
levels. The first level provides UV protection
exclusively, while a second protects against UV
rays and blue light. A third level delivers comprehensive
light protection. Light protection levels
can be exactly customized to suit the specific
requirements of the active ingredient. Additional
integrated functionalities also are available, including
detachable documentation labels for
vaccination cards or patients' medical records; inspection
windows for checking syringe contents
in unadulterated color; and graduations for correct
dosing of injections.
Schreiner MediPharm
www.schreiner-medipharm.com
Single-Use Real-Time Sublimation
Front Monitoring System for GMP
Freeze-Dryers
The Sublime sensor is capable of monitoring the
advance of the sublimation front in real time in
GMP freeze-drying processes. The single-use
probe contains five independent temperature
sensors including
wireless communication
which is placed within the vial, allowing it to
monitor the advance of the sublimation front
accurately, a key to optimize the primary drying
steps in lyophilization processes. Sublime
probes are coated with an FDA approved material
and are available in 5 different formats to
fit in any vial size from 2R to 100R. A single system
can hold up to 50 probes per freeze drying
batch. Without cables or batteries, the probes
work with a patented wireless power transmission
technology and with a reading interval of 1
minute and can work seamless between -60ºC
and +60ºC.
Telstar
www.telstar.com
http://www.iwk.de/en http://www.schreiner-medipharm.com http://www.omegadesign.com http://www.telstar.com

APR Sept/Oct 2023

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

INSIDER INSIGHT - From Guidelines to Standards: Why Comprehensive AI Regulation is Essential to Spurring Innovation
BIOPHARMACEUTICAL - Aseptic Process Simulation: Cell and Gene Therapy Manufacture
FORMULATION & DEVELOPMENT - Challenges of Analytical Validation for ATMPs
QC Corner - The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
MICROBIOLOGY - Standardized, Scalable And Efficient: Producing Recombinant Factor C to Quality Standards
FORMULATION AND DEVELOPMENT - R Code to Estimate Probability of Passing USP Dissolution Test
FORMULATION AND DEVELOPMENT - Cloud Computing for Drug Discovery: The Time is Now
CGT CIRCUIT - Navigating the Complex Testing Strategies for Viral Vector-based Gene Therapies
MANUFACTURING - Simplifying Finished Product Manufacturer Site Transfer Variations
FORMULATION AND DEVELOPMENT - Advancing Regulatory Compliance with Natural Language Processing
DRUG DELIVERY - Finding a Greater Vantage Point for Creating Green Therapies
WHITEPAPER - Microbial Testing for the Pharmaceutical Industry
Facility Tour - Eurofins BioPharma Product Testing
ROUNDTABLE - Drug Delivery
MANUFACTURING - Accelerating Biologics R&D with Unified Software and Data Flows
An Interview with Jason Downing, Senior Product Manager, TriLink BioTechnologies®
FORMULATION AND DEVELOPMENT - The Role of Data in the Pharmaceutical Lifecycle
BIOPHARMACEUTICAL - Uniting Quality Expectations on Reinvigorated Biopharma Campuses
WHITEPAPER - VITAMIN C – Tableting with LUBRITAB® RBW Lubricant
WHITEPAPER - Leveraging Analytical Technology Process for CMC
BIOPHARMACEUTICAL - Maximizing the Commercialization Potential of Cell and Gene Therapies
MICROBIOLOGY - Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
VENDOR VIEWPOINT - Continuous & Intervention-Free Microbial Monitoring
APR Sept/Oct 2023 - Cover1
APR Sept/Oct 2023 - Cover2
APR Sept/Oct 2023 - 1
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APR Sept/Oct 2023 - 26
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APR Sept/Oct 2023 - 29
APR Sept/Oct 2023 - 30
APR Sept/Oct 2023 - INSIDER INSIGHT - From Guidelines to Standards: Why Comprehensive AI Regulation is Essential to Spurring Innovation
APR Sept/Oct 2023 - 32
APR Sept/Oct 2023 - 33
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Aseptic Process Simulation: Cell and Gene Therapy Manufacture
APR Sept/Oct 2023 - 35
APR Sept/Oct 2023 - 36
APR Sept/Oct 2023 - 37
APR Sept/Oct 2023 - 38
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APR Sept/Oct 2023 - 40
APR Sept/Oct 2023 - 41
APR Sept/Oct 2023 - 42
APR Sept/Oct 2023 - 43
APR Sept/Oct 2023 - FORMULATION & DEVELOPMENT - Challenges of Analytical Validation for ATMPs
APR Sept/Oct 2023 - 45
APR Sept/Oct 2023 - 46
APR Sept/Oct 2023 - 47
APR Sept/Oct 2023 - 48
APR Sept/Oct 2023 - 49
APR Sept/Oct 2023 - QC Corner - The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
APR Sept/Oct 2023 - 51
APR Sept/Oct 2023 - MICROBIOLOGY - Standardized, Scalable And Efficient: Producing Recombinant Factor C to Quality Standards
APR Sept/Oct 2023 - 53
APR Sept/Oct 2023 - 54
APR Sept/Oct 2023 - 55
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - R Code to Estimate Probability of Passing USP Dissolution Test
APR Sept/Oct 2023 - 57
APR Sept/Oct 2023 - 58
APR Sept/Oct 2023 - 59
APR Sept/Oct 2023 - 60
APR Sept/Oct 2023 - 61
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - Cloud Computing for Drug Discovery: The Time is Now
APR Sept/Oct 2023 - 63
APR Sept/Oct 2023 - 64
APR Sept/Oct 2023 - 65
APR Sept/Oct 2023 - 66
APR Sept/Oct 2023 - 67
APR Sept/Oct 2023 - CGT CIRCUIT - Navigating the Complex Testing Strategies for Viral Vector-based Gene Therapies
APR Sept/Oct 2023 - 69
APR Sept/Oct 2023 - MANUFACTURING - Simplifying Finished Product Manufacturer Site Transfer Variations
APR Sept/Oct 2023 - 71
APR Sept/Oct 2023 - 72
APR Sept/Oct 2023 - 73
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - Advancing Regulatory Compliance with Natural Language Processing
APR Sept/Oct 2023 - 75
APR Sept/Oct 2023 - 76
APR Sept/Oct 2023 - 77
APR Sept/Oct 2023 - DRUG DELIVERY - Finding a Greater Vantage Point for Creating Green Therapies
APR Sept/Oct 2023 - 79
APR Sept/Oct 2023 - 80
APR Sept/Oct 2023 - 81
APR Sept/Oct 2023 - WHITEPAPER - Microbial Testing for the Pharmaceutical Industry
APR Sept/Oct 2023 - 83
APR Sept/Oct 2023 - 84
APR Sept/Oct 2023 - 85
APR Sept/Oct 2023 - Facility Tour - Eurofins BioPharma Product Testing
APR Sept/Oct 2023 - 87
APR Sept/Oct 2023 - 88
APR Sept/Oct 2023 - ROUNDTABLE - Drug Delivery
APR Sept/Oct 2023 - 90
APR Sept/Oct 2023 - 91
APR Sept/Oct 2023 - MANUFACTURING - Accelerating Biologics R&D with Unified Software and Data Flows
APR Sept/Oct 2023 - 93
APR Sept/Oct 2023 - An Interview with Jason Downing, Senior Product Manager, TriLink BioTechnologies®
APR Sept/Oct 2023 - 95
APR Sept/Oct 2023 - FORMULATION AND DEVELOPMENT - The Role of Data in the Pharmaceutical Lifecycle
APR Sept/Oct 2023 - 97
APR Sept/Oct 2023 - 98
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Uniting Quality Expectations on Reinvigorated Biopharma Campuses
APR Sept/Oct 2023 - 100
APR Sept/Oct 2023 - 101
APR Sept/Oct 2023 - WHITEPAPER - VITAMIN C – Tableting with LUBRITAB® RBW Lubricant
APR Sept/Oct 2023 - 103
APR Sept/Oct 2023 - WHITEPAPER - Leveraging Analytical Technology Process for CMC
APR Sept/Oct 2023 - 105
APR Sept/Oct 2023 - 106
APR Sept/Oct 2023 - BIOPHARMACEUTICAL - Maximizing the Commercialization Potential of Cell and Gene Therapies
APR Sept/Oct 2023 - 108
APR Sept/Oct 2023 - 109
APR Sept/Oct 2023 - MICROBIOLOGY - Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
APR Sept/Oct 2023 - 111
APR Sept/Oct 2023 - 112
APR Sept/Oct 2023 - 113
APR Sept/Oct 2023 - VENDOR VIEWPOINT - Continuous & Intervention-Free Microbial Monitoring
APR Sept/Oct 2023 - 115
APR Sept/Oct 2023 - 116
APR Sept/Oct 2023 - 117
APR Sept/Oct 2023 - 118
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APR Sept/Oct 2023 - Cover3
APR Sept/Oct 2023 - Cover4
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