Professional Documents
Culture Documents
Responsibilities
► Manage BINDER Subsidiary for Sales and Service
in North, Central and South America
► 12 Years with BINDER
► 25 years in the Instrument & Equipment Industry
► Located in New York, USA
Uwe Ross
President BINDER Inc.
Phone: +1 631 224 4340 x 112
Email: uross@binder-world.com Experience
► Research and Development Engineer
► Product Manager
Education
► Business Development Manager
► German Air Force Academy Graduate
► Marketing Director
► BSEE Electrical Engineering
► Divisional Vice President
► MSEE Information Technology
DQ Design Qualification
IQ Installation Qualification Equipment
OQ Operating Qualification Validation
PQ Process Qualification
+
GMP
+
GMP
3 Scale- 4 5
1 API 2 Pre- 6 On-
up batch Registration Follow
discovery formulation
batch going
-up
Pre-clinical:
Step 1 Stress test with the API at temperatures from 25°C to 70°C relative humidity up to 75% up to 3 months
(Is the active Ingredient temperature and humidity stable?)
Step 3 Stress tests with one or more batches to determine expiration date, storage conditions and
parameter for long term testing
(Determine packaging, storage and shelf life!)
Clinical:
Step 4 Long term and accelerated testing of 3 production scale batches API and FPP duration up to 12
month
(Long Term Test of different batches!)
Commercialization:
Step 5 Stability tests of 3 production batches of API and FPP duration up to 60 month
Q1D Bracketing and matrixing designs for stability testing of new drug substances
and products
– Annex to Q1A(R2) Guidance on reducing the amount of testing
► Q1E Evaluation of stability data
Annex to Q1A(R2)
Q1F Stability data package for registration applications in climatic zones III and IV
Withdrawn by ICH Replaced by WHO guideline on stability testing
BINDER
KBF P 720
GXP User
Requirements Requirements Procedural Testing PQ
Specification URS
DQ Documented Verification of
Vendor Selection
Staff Training
SOPs
Functional Requirement
Specification FRS Documented Maintenance Plan
5 °C above ambient 70 °C
Range
Make sure you stay away from temperatures too close to ambient [typical ambient is between 18º C and 32º C]
– Fluctuation
Temperature Tolerance over Time
@ Mid Chamber Location
Direct Heat
? !
Humidity Generation
• Water Bath
• Spray
• Steam Generator
• Pressurized Steam Generator
Water Disposal
URo 06/27/2016 Page 21
Humidity Source
Consider:
• Consistent Water Quality
• Sediments and impurities
• Pressure
URo 06/27/2016 Page 22
Humidity Generation
Humidity Generation
Example:
BINDER KBF 720 Product C
+ 25°C / 60 % RH 2 min 15 min
+ 40°C / 75% RH 6 min 48 min
Liquid
Dew point
Vapor
Water Management:
• Management means:
Humidity that does not change the temperature in chamber and
everything taken care of from intake to drain
Consider:
Condensation can be hidden in the
product specification
Light Cassette
Door Light Wall Light
Uniformity and Intensity
changes from front of
shelf to back or from
one side to the other
To achieve the specified light spectrum two different light bulbs are required
11000 11000
10000 10000
9000 9000
8000 rear 8000 rear
7000 7000
6000 6000
5000 5000
4000 4000
3000 middle 3000 middle
2000 2000
1000 1000
0 0
1 2 1 2
3 front 3 front
4 5 4 5
0-1000 Standard
1000-2000 lights
2000-3000 3000-4000 0-1000 BINDER Q1B Synergy
1000-2000 Light
2000-3000 3000-4000
4000-5000 5000-6000 6000-7000 7000-8000 4000-5000 5000-6000 6000-7000 7000-8000
8000-9000 9000-10000 10000-11000 8000-9000 9000-10000 10000-11000
100% 100%
100%
70%
100% 0%
Spherical sensor measures true dosage Planar sensor measures a fraction of dosage
Refrigeration Source
Peltier Cooling
Compressor Cooling
Power Supply
Heat Dissipation
Computer Interface
Alarms
Accessories
Service