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DURAN® PURE is a range of high-quality bottles
and closures developed for the requirements of
GMP manufacturing in the pharmaceutical and
biotech industry




PURE

Proven for
Pharma­ceutical
Production
Unmatched
Features
Regulatory
Support
Excellent
Quality
previous next



PROVEN FOR
PHARMA­CEUTICAL
PRODUCTION

 * GMP manufacturing of pharmaceutical drugs
   and biotech products
 * Storage and transport of
   * active pharmaceutical ingredients (APIs)
   * bulk drug intermediates
   * excipients
   * media
     
     
     

Brochure: DURAN® PURE

Flyer: DURAN® PURE GL 45

Flyer: DURAN® PURE GLS 80®

For product enquiries please contact: pharma@dwk.com


UNMATCHED
FEATURES

 * DURAN® PURE bottles made from
   Type I borosilicate glass
 * Bottle volume range from 25 ml - 20 l
 * Thread sizes GL 25, GL 45 and GLS 80®
 * Protective cover prevents contamination
   inside the bottle
 * Amber colored bottles available for
   light sensitive products
 * DURAN® PURE screw caps made from
   inert PFA and PSU
 * Assembled PTFE coated silicone seal
 * Lip seal design available
   
   
   

Brochure: DURAN® PURE

Flyer: DURAN® PURE GL 45

Flyer: DURAN® PURE GLS 80®

For product enquiries please contact: pharma@dwk.com


REGULATORY
SUPPORT

 * Single batch delivery
 * Certificate of analysis (CoA)
 * 100% traceability of all manufacturing steps
 * Complete quality documentation
 * Extractable reports available
 * Supplier questionnaires and audits
 * Change control management
 * Drug Master Files
   
   
   

Brochure: DURAN® PURE

Flyer: DURAN® PURE GL 45

Flyer: DURAN® PURE GLS 80®

For product enquiries please contact: pharma@dwk.com


EXCELLENT
QUALITY

 * DURAN® PURE bottles produced with
   100% visual inspection
 * Enhanced in-process control (IPC)
 * Assembly of protective covers directly at
   manufacturing line
 * Analysis of hydrolytic resistance
   acc. to EP, USP and JP
 * Full process control from raw materials
   to finished goods
 * DURAN® PURE screw caps manufactured
   in clean rooms
 * Tight visual and dimensional inspection
 * Quality assurance agreements
   
   
   

Brochure: DURAN® PURE

Flyer: DURAN® PURE GL 45

Flyer: DURAN® PURE GLS 80®

For product enquiries please contact: pharma@dwk.com




DURAN® PURE FOR GMP MANUFACTURING IN THE PHARMACEUTICAL AND BIOTECH INDUSTRY

In recent years, quality requirements in the pharmaceutical industry have
continuously been rising. This development is driven by a growing number of
highly sensitive biotech products, increasing demands from regulatory
authorities, tighter international guidelines and other factors.

 



Pharmaceutical Packaging
Primary packaging which gets in direct contact with active pharmaceutical
ingredients (APIs) is an important part of (bio)pharmaceutical products.
Packaging materials must meet high requirements. Apart from protecting the
product, it is critical to avoid interactions between the active ingredient and
the packaging material. This is in particular demanding for biotech products
consisting of complex molecules which are – due to their nature – very sensitive
towards contact materials.

Qualification and validation processes of primary packaging systems at companies
in the pharmaceutical and biotech industry include extractables and leachables
testing as well as stability studies to prove suitability of use for a specific
(bio)pharmaceutical product. This assessment involves use of significant
resources and high cost. Objective is to assure efficacy and safety of the
product for patients.

Glass is particularly suitable for primary packaging because this material is
chemically and thermally very durable and inert. The highest quality standards
are fulfilled by Type I borosilicate glass which shows due to its chemical
composition excellent hydrolytic resistance.


DURAN® PURE

The product portfolio is a range of high-quality glass bottles and plastic
closures for storage and transport of APIs, intermediates, excipients and media.
The main application area is in sterile manufacturing of pharmaceutical and
biotech products according to Good Manufacturing Practice (GMP). For more
information please contact: pharma@dwk.com.



DURAN® PURE Bottles
This product line includes a series of bottles manufactured from DURAN® glass
(Type I borosilicate glass 3.3) with DWK Life Sciences’ long-standing expertise
in glass molding technology.

DURAN® PURE Bottles are offered in a size range from 25 ml – 20 l for the neck
sizes GL 25, GL 45 and from 500 ml – 20 l for the wide neck design GLS 80®. All
bottles are closed with protective covers which are assembled onto the bottles
directly at the manufacturing line. This prevents contamination of the glass
surface inside the bottles during storage and transport.

Since a number of pharmaceutical and biotech products is light sensitive, DWK
Life Sciences offers DURAN® PURE Bottles also in amber colored version. For this
purpose, DWK Life Sciences utilizes an amber coloring process on the outer
surface of clear glass bottles. The contact material of the active ingredient on
the interior glass surface is the same as in the case of clear glass bottles.
Amber colored DURAN® PURE Bottles comply with a light transmission rate below
10% in the wave length range from 290–450 nm as stipulated by international
pharmacopoeias.

DURAN® PURE Bottles are manufactured with additional personal at the line,
undergo 100% visual inspection and enhanced in-process control (IPC) to warrant
highest quality standards.

DWK Life Sciences delivers DURAN® PURE Bottles as single batches to the
customers. The retrace code (batch number) which is included in the print of the
bottles ensures 100% traceability of data from all manufacturing steps. DURAN®
PURE batch certificates are issued as Certificates of Analysis (CoA) including
data on hydrolytic resistance according to EP, USP and JP measured for the
individual batch. Based on these data, DWK Life Sciences confirms compliance
with the requirements of Type I glass. Certificates of Analysis are available
for download on the DWK Life Sciences homepage and will upon request be
forwarded to the customer.

The DURAN® PURE Bottle line is covered by change control management. This means
customers will be informed in advance about any changes of products or
processes.

Comprehensive quality documentation of DURAN® PURE Bottles including product
specifications, statements on BSE TSE, food contact and more is available for
download on the DWK Life Sciences homepage and will be forwarded on request. In
addition, an extractables report is provided to support customers in DOE (design
of experiments) of own extractables and leachables studies.

DWK Life Sciences has submitted a Drug Master File (DMF) Type III for DURAN®
PURE Bottles. Customers can reference the DMF in case of marketing applications
for new drugs, biotech products, biosimilars and generics.

DURAN® PURE Screw Caps
DWK Life Sciences’ range of high-quality closures consist of the DURAN® PURE
Premium Screw Caps GL 25 und GL 45 made from PFA (fluoropolymer) and the DURAN®
PURE GLS 80® Screw Cap from PSU (polyarylsulfone). These closures include
pre-assembled, PTFE coated silicone seals and are ideally suited for the DURAN®
PURE bottle series with GL 25, GL 45 and GLS 80® neck sizes.

In addition, DWK Life Sciences offers the DURAN® PURE Premium Lip Seal Cap (GL
45) which has in the cap design an integrated lip seal. This product is an
alternative closure for DURAN® PURE GL 45 bottles.

DURAN® PURE Screw Caps are chemically and thermally very inert, compatible with
autoclaving and other common sterilization methods. They are manufactured and
packaged in clean rooms, come with the DURAN® PURE features and services. These
are single-batch delivery, batch certificates (Certificates of Analysis) and
100% traceability of all manufacturing and assembly steps. The retrace codes are
marked on the products. Change control management, a full set of quality
documents including statements on elemental impurities (ICH Q3D) and residual
solvents (ICH Q3C) are available. DWK Life Sciences has also submitted Drug
Master Files (DMF) Type III for DURAN® PURE Screw Caps.

The batch certificates (Certificates of Analysis) of DURAN® PURE Screw Caps
include dimensional values and results of visual inspection for the individual
batch. In addition, compliance with pharmacopoeias and other international
standards is confirmed. Extractables profiles assist in evaluation of the
products and planning of extractables & leachables studies by the customer.

The DURAN® PURE Premium Pouring Ring GL 45 from PFA complements the DURAN PURE
line as a solution for easy pouring of liquids during the drug manufacturing
process. The product is manufactured and packaged in a clean room, delivered as
single-batch with batch certificate (Certificate of Analysis) and 100%
traceability.  Quality documentation and change control management are part of
the offering.


THE API BOTTLE SYSTEM

DWK Life Sciences fully supports the qualification and validation process at the
customer. This starts with DURAN® PURE samples for first product evaluation,
goes through quality documentation and supplier questionnaires up to supplier
site audits, regulatory support and technical service. For more information
please contact: pharma@dwk.com.

The DURAN® PURE product line is due to its features and quality attributes a
container closure system of choice for the pharmaceutical and biotech
manufacturing process.


ARTICLE INFORMATION

DURAN® PURE Bottles

Volume
[ml] DIN thread GL Bottles per box
[pcs.] Bottles per pallet
[pcs.] Article number
clear glass Article number
amber colored 25 25 10 940 81 801 14 01 81 806 14 06 100 45 10 540 81 801 24 06
81 806 24 02 250 45 10 280 81 801 36 08 81 806 36 04 500 45 10 360 81 801 44 07
81 806 44 03 1 000 45 10 210 81 801 54 03 81 806 54 08 2 000 45 10 120 81 801 63
05 81 806 63 01 5 000 45 1 48 81 801 73 01 81 806 73 06 10 000 45 1 30 81 801 86
06 81 806 86 02 20 000 45 1 12 81 801 91 05 81 806 91 01

 

DURAN® PURE Screw Caps

Description DIN thread GL Products per PE bag
[pcs.] Article number DURAN® PURE Premium Screw Cap 25 5 89 108 13 06 DURAN®
PURE Premium Screw Cap 45 5 89 108 86 79 DURAN® PURE Premium Lip Seal Cap 45 5
89 886 28 02 DURAN® PURE Silicone Seal, PTFE coated 25 10 29 248 14 56 DURAN®
PURE Silicone Seal, PTFE coated 45 10 29 248 29 58 DURAN® PURE Premium Pouring
Ring 45 5 89 108 86 78

 

DURAN® PURE GLS 80® Bottles

Volume
[ml] Bottles per box
[pcs.] Bottles per pallet
[pcs.] Article number
clear glass Article number
amber colored 500 10 280 81 860 44 03 81 866 44 09 1 000 10 210 81 860 54 08 81
866 54 05 2 000 10 120 81 860 63 01 81 866 63 07 5 000 1 48 81 860 73 06 81 866
73 03 10 000 1 30 81 860 86 02 81 866 86 08 20 000 1 12 81 860 91 01 81 866 91
07

 

DURAN® PURE GLS 80® Screw Cap

Description Products per PE bag
[pcs.] Article number DURAN® PURE GLS 80® Screw Cap 1 89 116 91 09 DURAN® PURE
Silicone Seal, PTFE coated 10 29 248 91 02

 

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 * Disclaimer
 * Data protection declaration
 * Imprint

 

© 2023 DWK Life Sciences


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We use cookies to provide you with an optimal website experience. This includes
cookies that are necessary for the operation of the site and for the control of
our commercial business objectives, as well as cookies that are only used for
anonymous statistical purposes, for comfort settings or to display personalized
content. Decide for yourself which cookies you want to allow. Please note that
based on your settings, not all functionalities of the site may be available.
More information in our privacy policy.
Basic These cookies are necessary for the operation of the site and enable, for
example, security-related functionalities.
Comfort We use these cookies to make the use of the site easier for you. In
order to further improve our website, we collect anonymous data for statistics
and analysis.

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