01 Services.
Stability Storage
Extensive stability and photostability storage capacity across all ICH conditions for API’s and Formulated Products for Human and Veterinary use.
Over 300 m3 of available space in state of the art walk in chambers, climatic cabinets and freezer storage.
Photostability
Precise light testing under controlled climate conditions (ICH Q1B, Option2).
Emergency Plans
Permanent and responsive stability contingency plans for disaster recovery and business continuity emergency storage.
Other Services
Bluestabil can also provide Transportation to client facilities and Chemical Services analysis (subcontracted) upon request.
cGMP CERTIFIED BY:
If you'd like to learn more about our services
02 Climatic Zones.
BLUESTABIL (ICH and Non-ICH CONDITIONS)
-20ºC
5ºC
25ºC
60%rh
30ºC
65%rh
30ºC
75%rh
40ºC
75%rh
Photostability
(ICH Q1B, option 2)
Additional non-ICH conditionsavailable upon request
03 Facilities.
300m3
of dedicated stability storage across different climatic chambers, cabinets and freezers.
24hours
monitoring and recording of all operating conditions with alarm detection systems.
BACKUP
generator to ensure a supported system of electrical energy to cameras and data.
DATA
management software CFR21 PART 11 compliant.
PERMANENT
surveillance and security, 365 days a year.
LOCAL
assistance support to ensure quick reaction time and prevent excursions.
QUALIFICATION
according to ICH guidelines.
TRACKING
system with intelligent code bar reading.
04 Connected
user experience.
At Bluestabil we value transparency and open lines communication with our partners through real-time access to sample and trial information. Each partner gets access to a secure CLIENT AREA in Bluestabil proprietary management software, to:
Manage all ongoing stability studies.
Send and withdraw samples.
Access real-time climatic conditions inside the chambers.
Receive alarm notifications in real-time.
Get an explanation from the operation team for each event.
Get monthly conformity declarations of chambers stability conditions.
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05 About us.
STABILITY AND PHOTOSTABILITY STORAGE.
Bluestabil is a leading European provider of stability storage. We provide a full range of ICH conditions, aligned with the best practices in the industry. Customer experience and transparency are key values of our operation. A truly connected working partnership is encouraged and valued at Bluestabil.
PARTNERS
"
Throughout these years of collaboration, it is accurate to say that the challenges presented by us have been increasing in both number and complexity. Likewise, it is true to say that the Bluestabil team has consistently met our needs. We see Bluestabil not only as a business partner, but as a valuable ally that grows with us in order to provide a fast, effective and aligned response to the standards of quality and demand required by us and our customers.
QUALITY MANAGER AT HOVIONE
"
Hiring Bluestabil services, avoided the cost and time involved in the purchase of a new equipment but, more than that, it allowed - in an emergency situation - to have a ready-to-deploy backup storage plan under ICH stability conditions. I cannot fail to mention the constant information on the conditions under which the samples are stored, as well as the availability for any other information and collaboration. I consider it an excellent service that I would recommend.
TECHNICAL DIRECTOR AT IBERFAR
"
The service provided by Bluestabil meets the needs of the Pharmaceutical Industry constituting an added value for this segment of activity. The Quality System implemented ensures compliance with good manufacturing practices and compliance with applicable international guidelines.
QUALITY MANAGER AT LABORATÓRIOS ATRAL
06 Contacts.
Bluestabil
Sintra Business Park, pavilhão nº6, fração CU
Zona Industrial da Abrunheira
2710-089 Sintra • Portugal
Contact us today at
to evaluate how Bluestabil can help you accomplish a successful, efficient and competitive solution for your stability studies.
for comercial support if you need stability storage.