COLD STORAGE SOLUTIONS - +2 C TO +20 C / -40 C TO -80 C - FOR THE PHARMACEUTICAL, BIOTECHNICAL INDUSTRY, Arctiko Engineering
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COLD STORAGE SOLUTIONS
+2°C TO +20°C / -40°C TO -80°C
FOR THE PHARMACEUTICAL, BIOTECHNICAL INDUSTRY,
HEALTH CARE ORGANISATIONS AND NGO’S
Arctiko engineering PROJECT ENGINEERING OF COLD STORAGE ROOMS FOR THE PHARMACEUTICAL AND BIOTECHNICAL INDUSTRY Arctiko has in the last 8 years been involved in cold storage solutions. We provide simple storage solutions for medicine or vaccines at +2°C / +8°C, and high end GMP validated storage / blast freezer solutions in the temperature range -40°C to -80°C. Among our customers are some of the world’s largest pharmaceutical, medical and biotechnical companies. Our main focus is reliability, temperature uniformity, redundancy, sustainability and GMP documentation for the pharmaceutical and biotechnical industry In-house consulting Project management GMP validation Automation specialists Mechanical engineering 3D drawings Certifications About us Our main focus is reliability, temperature uniformity, redundancy, sustainability and GMP documentation for the pharmaceutical and biotechnical industries. We are familiar with the strict and often complicated requirements from the pharmaceutical industry. 2
Certification
ISO 9001
ISO 9001 is the most widely used International standard in
the world. It streamlines and documents Arctiko’s working
processes and ensures that production always meets the
high quality expectations of Arctiko’s partners.
Arctiko uses the ISO 9001 standard in all business
processes within R&D, sales, marketing, manufacturing and
with continuous monitoring and optimization of business
processes and manufacturing methods. This ensures that
in all areas, not just commercial applications, Arctiko will
meet customer expectations/requirements in
communications, documentations, deliveries and
administration.
ISO 13485
ISO 13485 is a standard for the design and manufacture of
medical equipment. It is an independent standard
certification that is generally harmonized with ISO 9001.
The standard has been prepared in accordance with the
European Commission with a view to the essential
requirements of EU directives for medical devices and CE
marking.
For Arctiko, the ISO 13485 is a quality management system
ensuring that our products meet the EU directive 93/42/
EEC for medical devices. Class I devices are approved by
Arctiko, whereas Class II equipment must be approved by
an external certification company. For both classifications,
Arctiko has prepared a technical file verifying that the
equipment meets the essential requirements of EU
directive 93/42/EEC for medical devices and CE marking.
Certification ensures that when choosing Arctiko products
classified as Class I and II medical devices, Arctiko’s
customers can trust our statements of high quality at all
times.
MEDICAL DEVICES DIRECTIVE
Again Arctiko has raised the bargain and achieved the EU
directive 93/42/EEC for medical devices & CE marking for
Class II equipment.
This ensures that Arctiko partners and customers at any
time can trust our statements of high quality when
choosing Arctiko products which are classified as Medical
devices class I and Class II. Having this certification is also
known as a “Symbol of Safety” worldwide.
EC Certificate
Certificate of
Registration Certificate No.:
Production Qua
lity Assurance
EU1502403
Order No.:
279173
Date: 2015-02-13
We hereby certify
legislation “Regul that an examination has
ation no. 1690 been carried
no. 6 of 12 th Januar of 15 th Decem out following
y 1995 relating ber 2005 the requirements
law to which the
undersigned to medical devices relating to medical devices of the nationa
l
appendix no. is subjected, , transpo pursua
2, volume 2A/3 confer EEA agreemsing directive 93/42/EEC nt to act
conforms to the A, goods, chapte ent, into Norwegian
relevant provisio r XXX”. We certify proposition no. 100 (1991-9
This is to certify ns of the Annex that the produc 2)
that the quality given below: tion quality systemspecial
manageme
nt system of Manufacturer:
ARCTIKO A/S
Lammefjordve
j5
Esbjerg N, 6715
ARCTIKO A/S
Denmark
Device catego
rie(s):
MD 1101 Blood
GMDN code: bank refrigerator
See page 2 to
Main site: Lamm this certificate
efjordsvej 5, Models:
6715 Esbjerg See page 2 to
N, Denmark this certificate
Risk class as
defined by
has been assess the manufacturer: IIa
ed and registe Standards/pro
red by Interte visions:
k as conforming The audit of the
to the require quality system
SS-EN ISO 134 ments of according to the was based upon
provisions in and assessed
85:2012
Date of audit: Annex V of the
2014-09-25/26 EC-Directive
93/42/EEC.
The quality mana End of the validity
gement system : 2020-03-01
is applicable
Research, Develo to Nemko EC notifica
pment, Sales tion No.: 0470
and
and laboratory Services of ultra low tempe Remarks:
refrigerators rature freeze
and freezers rs -
Certificate Numb
er: On this basis
Initial Certific 52240-01 the manufacturer
ation Date: Declaration of or the Europe
Certificate Issue Confor an
Date: December 14
2010 notification numbe mity and affix the CE-ma authorised representative
Certificate Expiry December 9 r to each conform rking as indicate may draw up
Date: required by the ing product as d below an EC / EEA
2016 EC directive will long as the conform together with the Nemko
February 28 rests with the be fulfilled by ity audit and inspect EC
2019 manufacturer the manufacturer
or his represe and the factory ion procedure
ntative in accord . The product
ance with Counci
l Directive 85/374 liability
/EEC.
Thomas Andersso Arild R. Hansgå
Intertek Certifica n, CEO rd
tion AB For Nemko AS
P.O. Box 1103,
In the issuance
SE-164 22 Kista,
of this certificate Sweden
accordance
with the agreed , Intertek assumes no liability
maintaining upon Certificatio to any party
their system n Agreemen other than to
confirmed via in accordanc t. This certificate the Client, and
email at certificate e with Intertek’s ’s validity is subject then only in
.validation@intertek.crequirements for systems to the organizatio
om or by scanning certification. n Nemko Norway
the code to Validity may
The certificate the right with be Nemko AS, Gaustadallé
remains the a smartphon en 30,
e.
property of Intertek,
to whom it must
TEL +47 22
96 03 30 FAX +47 P.O. Box 73 Blindern, 0314
be returned ENTERPRISE 22 96 05 50 EMAIL Oslo, Norway
upon request. NUMBER NO9744045 info@nemko.com
32
2013-09-22
nemko.com/no
Page 1 of 2
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PRODUCTS
Our customers often have specific requirements. It is important for us to meet the requirements and
provide the best possible solution at a fair and competitive price. We are very strong in the
temperature range from -40°C to -80°C in both storage and blast freezers. We can even provide a
modular and flexible solution with three freezers in one unit -40°C / -80°C and blast to -70°C.
We are able to design and build the exact solution you require and need. Our production
facility is located in Denmark. Products are 90% finished when they leave our factory,
ready for installation and commission on site.
With improved focus on the environment, we offer freezers based on
carbon-dioxide (CO₂) refrigerant, which offers lowest possible
impact on the environment, very low power consumption,
reliability, simplicity in design as well as
maintenance.
4
5
PHARMA/BIOTECH LOW TEMPERATURE -40°C / -60°C / -70°C / -80°C BLAST FREEZER Our customers often have specific requirements. It is important for us to meet the requirements and provide the best possible solution at a fair and competitive price. We are very strong in the temperature range from -40°C to -80°C in both storage and blast freezers. We can even provide a modular and flexible solution with three freezers in one unit -40°C / -80°C and blast to -70°C. We are able to design and build the exact solution you require and need. Our production facility is located in Denmark. Products are 90% finished when they leave our factory, ready for installation and commission on site. 6
PHARMA/BIOTECH
7
VACCINE STORAGE +2°C / +8°C COLD ROOMS -18°C / -30°C FREEZER ROOMS Arctiko has been involved with cold storage solutions for the past eight years. We provide simple storage solutions for medicine or vaccines at +2°C / +8°C, and high-end GMP validated storage/blast freezer solutions in the temperature range -40°C to -80°C. We can count some of the world’s largest pharmaceutical, medical and biotechnical companies among our customers. Our main focus is reliability, temperature uniformity, redundancy, sustainability and GMP documentation for the pharmaceutical and biotechnical industries. We are familiar with the strict and often complicated requirements from the pharmaceutical industry. 8
VACCINE STORAGE
9
SOLAR VACCINE STORAGE +2°C / +8°C COLD ROOMS -18°C / -30°C FREEZER ROOMS Arctiko has been involved with cold storage solutions for the past eight years. We provide simple storage solutions for medicine or vaccines at +2°C / +8°C, and high-end GMP validated storage/blast freezer solutions in the temperature range -40°C to -80°C. We can count some of the world’s largest pharmaceutical, medical and biotechnical companies among our customers. Our main focus is reliability, temperature uniformity, redundancy, sustainability and GMP documentation for the pharmaceutical and biotechnical industries. We are familiar with the strict and often complicated requirements from the pharmaceutical industry. 10
SOLAR VACCINE STORAGE
11ARCTIKO A/S
Lammefjordsvej 5
6715 Esbjerg N
MISENA.DK / 2017
Denmark
+45 70 20 03 28
www.arctikoengineering.com
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