Customer Support: +1 416-401-8730

Login to i2i Subscription Intertek.com
  • There are no items in your cart
Please enter a keyword to search
Advanced search
Home
BSI
BS EN ISO 8362-5:2016

BS EN ISO 8362-5:2016

Current

Current

The latest, up-to-date edition.

Injection containers and accessories Freeze drying closures for injection vials

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

03-31-2016

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Shape and dimensions
5 Designation
6 Material
7 Performance requirements
8 Labelling
Annex A (informative) - Determination of moisture
Bibliography

Gives the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.

This part of ISO8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO8362-1 and ISO8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.

The dimensional requirements are not applicable to barrier-coated closures.

Closures specified in this part of ISO8362 are intended for single use only.

NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.

Committee
CH/212
DevelopmentNote
Supersedes 14/30304354 DC. (03/2016)
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
EN ISO 8362-5:2016 Identical
ISO 8362-5:2016 Identical

ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
ISO 2230:2002 Rubber products — Guidelines for storage
ISO 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 3302-2:2008 Rubber Tolerances for products Part 2: Geometrical tolerances
ISO 554:1976 Standard atmospheres for conditioning and/or testing — Specifications
ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods

View more information
US$160.51
Excluding Tax where applicable
USD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us