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Pure

P P
Proven for
Pharma­ceutical
Production
U U
Unmatched
Features
R R
Regulatory
Support
E E
Excellent
Quality

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


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


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


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


DURAN® PURE FOR GMP MANUFACUTRING 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 Caps
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