DURAN® PURE
DURAN? PURE
THE API BOTTLE SYSTEM
Biotech & Pharmaceutical GMP
In-Process and Packaging Container
DURAN? PURE is a range of high-quality bottles
and closures developed for the requirements
of GMP manufacturing in the pharmaceutical and
biotech industry.
Discover more:
duran-
PROVEN FOR
PHARMACEUTICAL
PRODUCTION
UNMATCHED
FEATURES
REGULATORY
SUPPORT
EXCELLENT
QUALITY
DURAN? PURE
THE API BOTTLE SYSTEM
APPLICATION
AREAS
? GMP manufacturing of pharmaceutical drugs
and biotech products
? Storage and transport of APIs, bulk drug intermediates,
excipients and media
RESEARCH &
DEVELOPMENT
PHARMACEUTICAL
PRODUCTION
FILL &
FINISH
Protective cover
Prevents contamination
during storage and transport
MEETS PHARMACEUTICAL
REQUIREMENTS
? Single batch delivery
? Certificate of Analysis
Article number
? 100% Design & Control Traceability
818014407
Article description
Production and inspection
The articles listed under article number are hereby con?rmed
to have been produced using a quality system conforming to
DIN ISO 9001. They comply with the quality standards identi?ed
in the speci?cation. The properties of DURAN? glassware comply
with standard DIN ISO 3585 (borosilicate glass 3.3).
The dimensions correspond to the standard ISO 4796-1.
Prior to delivery, all production batches are subjected to statistical
quality inspections corresponding to the standard DIN ISO 2859 -1.
'85$1 385( /DERUDWRU\ %RWWOH
*/ PO
Glass type
? Change control
Type 1
Retrace Code
10112327
Drawing no.
0335520-GZA-01694-A
DURAN? C Glass type 1
Composition:
81 %
SiO2
13 %
B2O3
4%
Na2O/K2O
2%
Al2O3
? Drug Master File
Number of packing units
per pallet
360
Date of manufacture
19.06.2019
? Original Brand Manufacturer
Chemical and physical properties:
Coe?cient of expansion:
3.3 x 10C6 KC1
Acid resistance:
Class 1 (DIN ISO 1776)
Hydrolytic resistance:
Class 1 (DIN ISO 719 / 720)
Alkali resistance:
Class 2 (ISO 695)
Directive conformity *:
USP, Ph.Eur., JP, ISO 4796-1
? Defined expiration date ISO 15378
All con?rmations and information in this certi?cate apply solely to
goods originating from DURAN?. For further processed products these
details are not binding.
Issued on
Approved on
12.07.2019
12.07.2019
Issued by (name)
Approved by (name)
M. Jefferson, Quality Management
Dr. A. Fries, PM Pharma
Signature
Signature
This document was issued electronically and is valid without signature.
DWK Life Sciences GmbH ? Hattenbergstrasse 10 ? 55122 Mainz, Germany
DWK-
Retrace Code: 10112327
Page 1 of 2
Broad size range
from 25 mL - 20 L
Clear glass and amber colored bottles are
available with different neck sizes
EP/USP Type I
borosilicate glass
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