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.

If you'd like to learn more about our services

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

WWW.HOVIONE.COM

"

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

WWW.IBERFAR.PT

"

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

WWW.ATRAL.COM

06 Contacts.

Bluestabil

Sintra Business Park, pavilhão nº6, fração CU
Zona Industrial da Abrunheira
2710-089 Sintra • Portugal

Contact us today at

geral.3s@isq.pt

to evaluate how Bluestabil can help you accomplish a successful, efficient and competitive solution for your stability studies.