Blend Uniformity - Prozess Technologie

Blend Uniformity - Prozess Technologie
PRODUCT OVERVIEW
Blend Uniformity
E600 SERIES
E800 SERIES
SUMMARY
SUCCESS IN PHARMA
Prozess has established itself as a leader in
the technically challenging and regulatory
complex pharmaceutical sector, and includes
16 of the top 20 global Big Pharma
companies as customers. We have delivered
over 100+ systems into primarily Pharma
applications.
FDA COMPLIANCE
Our software is fully compliant with the US
FDA’s strictest guidelines on electronic
records and signatures, 21 CFR Part 11, and
also is fully compliant with Good Automated
Manufacturing Practices (GAMP).
PAT/QbD
Our success has been fueled, in large part, by
leading manufacturing movements PAT
(Process Analytical Technology) and QbD
(Quality by Design). With pressure from the
FDA (United States Food and Drug
Administration), manufacturers are looking
to Prozess solutions to enable them to
produce products with consistent quality in a
shorter production window, while shrinking
waste and reducing overall production costs.
KEY BENEFITS
Real-time determination of blend uniformity
without manual sampling; no QC lab analysis
required
Increase in manufacturing efficiency
Automated report generation for every batch
Prevent under/over blending
Reduce blending time while ensuring
uniformity
1.314.932.2920
sales@prozesstech.com
www.prozesstech.com
Dry powder blending of pharmaceutical ingredients requires measurement of blend uniformity to determine
that the end point has been reached and all powders are uniformly distributed. Typically, measurements are
performed off line after manual sampling, or the blend uniformity is based solely on blending time. Both
methods have a negative impact on the efficiency of the production process. The rise of continuous manufacturing necessitates real-time measurements for use in blending feedback controls.
PROZESS SOLUTION
Near-infrared (NIR) spectroscopy is well established as a PAT tool for measuring blend uniformity. The Prozess
NIR Reveal E-Series measures via diffuse reflectance from the powder mixture and monitors the concentration
of the API (or APIs) during every rotation of a bin blender, tracking the change in measured concentration over
time. An internal accelerometer synchronizes measurements, so they are taken only when the powder blend is
in a position to be measured. When the concentrations no longer change, the mixture is uniformly blended.
Various statistical measures available in the Prozess software can be used to quantify this variation. Prozess
supplies two NIR-based solutions for blend uniformity determination, covering different wavelength ranges and
with different spectral resolution, measuring areas and measurement times.
For high potency APIs in low concentration formulations, Prozess also offers a light-induced fluorescence (LIF)
Reveal E-Series analyzer for blend uniformity, which measures the change in concentration of the API by
monitoring the fluorescence of the API as a result of ultraviolet (UV) excitation. This technique is very sensitive
and well suited for blends of low dose API formulations. In all other respects the NIR and LIF solutions share
operating features as well as the same user software.
Solutions designed for real-time blend uniformity measurements may be used in bin or V-blenders, feed
hoppers, continuous blending systems or in the feed frame of tablet presses. Options are available for contact
measurement probes or for measurements made through a window.
E-SERIES
DATASHEET
Blend Uniformity LIF
SYSTEM COMPONENTS
ENCLOSURE
Instrument enclosure is 341 mm long x 266 mm wide x 146 mm
high
Flexible conduit to Measuring Head: 1.6 m (other lengths
available)
Can be mounted directly on blender
SPECTROMETER
LIF spectrometer
Detection wavelength range: 300 - 1,000 nm
Spectral Resolution (approximate): 5 nm
PROCESS INTERFACE
Connected to spectrometer with flexible conduit.
Working distance from measuring head to sample is adjustable
Made to attach with a 4” tri-clamp (sanitary) fitting on a blender
unit.
Optimized for window measurements. Window kits sold
separately.
Integrated trigger switch to control sampling during blender
rotation
Measuring Head is 128 mm tall x 119 mm diameter
LED PUCK WITH 6 LEDS
Holds LEDs in place inside the Measuring Head or Insertion
Probe
Excitation wavelength(s) of LEDs can be specified at time of
order
Standard LEDs are offered in wavelengths starting from 280 nm
Any combination of 6 LEDs can be ordered to accommodate
various scenarios
LEDs and Fluorescence Filters are software controlled
KEY FEATURES
BUILTIN NETWORKING CAPABILITY
10/100 Mbit Ethernet with sealed connector
802.11A/G/N wireless support
Built in OPC
NOVAPAC™ / NOVAMATH™
SOFTWARE BUNDLE
NovaPAC Software for real-time process analyzer control,
measurement and data storage
NovaMath Software for chemometric modelling and predictions
AUTOMATED SYSTEMS SUITABILITY
Automated internal system suitability testing
Rapidly verify wavelength accuracy and photometric accuracy
Test schedule set by user through simple setting in the user
interface
BATTERIES / CHARGER
Two hot swappable batteries for continuous operation
Allows system use for a minimum of 4 hours
IP65-compliant enclosures
Charge Status Indicators on batteries and charger
Recharges two batteries at a time
Recharger configured for 110/240 VAC, 50/60 Hz input
AC POWER SUPPLY
For system use without batteries
Configured for 110/240 VAC, 50/60 Hz input
IP 65 compliant enclosure
FULL DOCUMENTATION PROVIDED
User Manuals and appropriate certificates
Executed Factory Acceptance Test (FAT) document
SYSTEM INTRODUCTION
Execution of installation over a period of 1 to 1.5 days
Includes acceptance testing to confirm system functionality
following installation
1.314.932.2920
sales@prozesstech.com
www.prozesstech.com
page 2
DATASHEET
Blend Uniformity NIR
SYSTEM COMPONENTS
ENCLOSURE
Instrument enclosure is 341 mm long x 266 mm wide x 146 mm
high
Flexible conduit to Measuring Head: 1.6 m (other lengths
available)
Can be mounted directly on blender
SPECTROMETER
NIR spectrometer
1100 - 2100 nm diode array detector
Spectral resolution < 5 nm
Integrated tungsten halogen light source
PROCESS INTERFACE
Connected to spectrometer with flexible conduit.
Working distance from measuring head to sample is adjustable
Adjustable spot size, 9 - 15 mm
Made to attach with a 4” tri-clamp (sanitary) fitting on a blender
window
Optimized for window measurements. Window kits sold
separately
Integrated trigger switch to control sampling during blender
rotation
Measuring Head is 128 mm tall x 119 mm diameter
KEY FEATURES
BUILTIN NETWORKING CAPABILITY
10/100 Mbit Ethernet with sealed connector
802.11A/G/N wireless support
Built in OPC
NOVAPAC™ / NOVAMATH™
SOFTWARE BUNDLE
NovaPAC Software for real-time process analyzer control,
measurement and data storage
NovaMath Software for chemometric modelling and predictions
AUTOMATED SYSTEMS SUITABILITY
Automated internal system suitability testing
Rapidly verify wavelength accuracy and photometric accuracy
Test schedule set by user through simple setting in the user
interface
BATTERIES / CHARGER
Two hot swappable batteries for continuous operation
Allows system use for a minimum of 4 hours
IP65-compliant enclosures
Charge Status Indicators on batteries and charger
Recharges two batteries at a time
Recharger configured for 110/240 VAC, 50/60 Hz input
AC POWER SUPPLY
For system use without batteries
Configured for 110/240 VAC, 50/60 Hz input
IP 65 compliant enclosure
FULL DOCUMENTATION PROVIDED
User Manuals and appropriate certificates
Executed Factory Acceptance Test (FAT) document
SYSTEM INTRODUCTION
Execution of installation over a period of 1 to 1.5 days
Includes acceptance testing to confirm system functionality
following installation
1.314.932.2920
sales@prozesstech.com
www.prozesstech.com
page 3
Blend Uniformity
LIF and NIR
AN EXTENSIBLE PLATFORM
DATASHEET
AVAILABLE OPTIONS
QUICK RELEASE INSTRUMENT
MOUNTING BRACKET
LIGHT
FLUSH DESIGN BLEND MONITOR
WINDOW ASSEMBLY
INTERFACE
CHASSIS
CALIBRATION / VALIDATION KIT
SCIENCE
INSTALLATION QUALIFICATION /
OPERATIONAL QUALIFICATION
COMMUNICATIONS
page 4
Execution of test plans to verify and
document the installation and
functional operation of the system at
the time of execution.
ANNUAL PREVENTIVE MAINTENANCE
Prozess Technologie’s expert field service
personnel can perform a suite of
preventive maintenance services at your
location.
PROCESS MEASUREMENT
made simple
Includes a blender-side quick release bracket
Enables quick and easy attachment to blender/blender bin, as
the bracket mates easily to the instrument
Quick release can be performed in seconds by a single person
Engineering Services available for fully custom blender/blender
bin fit
Engineering Services available to assist with installation of
bracket onto blender/blender bin
A 55 mm diameter clear aperture sapphire window sealed to a
316 stainless steel flange
The "inside" is completely flush with the bin lid surface to keep
powders from sticking
The outside is an integrated 4” sanitary flange
Glass-filled PTFE seal
O-ring secondary seal (silicone as standard, other materials
available on request)
Engineering Services available for modification of free issue
blender lid
Engineering Services available for insertion of window assembly
into lid
Engineering Services available for electro-polishing inside of
finished lid
We provide Certification of Compliance for all components that
have product contact
99% white reflectance standard
Black standard
Reflectance fluorescent standards, set of 4
Wavelength standard
Window spacer assembly
Includes 2 days of on-site IQ/OQ execution
Comprehensive test protocol as evidence of proper test
execution
Full operational testing including: start-up, shut-down, general
operation, instrument diagnostics, user accounts, security, and
audit trail
Execution of spectrometer validation routines
One on-site visit for scheduled preventive maintenance and
system validation, normally completed in one day.
All domestic travel time and expenses related to service visit are
included. Please contact Prozess for international travel
quotation.
Preventive maintenance includes execution and acceptance of
service test protocol. No parts or additional labor costs are
included for repairs found to be necessary while carrying out the
preventive maintenance.
Requires that the system be available and accessible and that a
full set of calibration standards to be available and within
certification date.
AVAILABLE PROCESS INTERFACES
1.314.932.2920
sales@prozesstech.com
www.prozesstech.com
MEASURING HEAD
Fiber coupled to enclosure with reinforced flexible conduit
DIMENSIONAL DRAWINGS
page 5
Blend Uniformity
E-SERIES
All dimensions in mm
Hot Swappable Battery Connections
WiFi Antenna
Ethernet Connection
On/Off Button
269
139
400
Quick Release Mounting System
Measurement Interface Connection
www.prozesstech.com
1.314.932.2920
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