Foil Package Integrity Testing ISO 4074

N

nurhakim

#1
Hi Cove,

There is one requirement in ISO 4074 to test for foil package integrity of condom foil at absolute pressure 20 plus minus 5 kPa. We test the package using wet vacuum method.
However I was a bit curious about the pressure setting where our gauge showed a range from 0 to -30 in Hg. Can we we apply unit conversion to obtain in kPa unit, and how to address the absolute pressure issue?

Thanks.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Package integrity testing ISO 4074

Hi,

760mmHg = 101.325kPa

0mmHg = 0kPa
-30mmHg = -4kPa

I think your gauge is showing gauge (relative) pressure. I'm not aware of an absolute negative pressure. In perfect vacuum you would have absolute pressure 0.

Absolute pressure 15-25kPa means a vacuum of about 85-75kPa (-75 to -85kPa relative pressure). It also depends on the barometric pressure at your geographic location, unless you test in a pressure regulated environment.

Cheers,
Ronen.
 
Last edited:
Thread starter Similar threads Forum Replies Date
D IEC 60601 Defibrillation protection test - Metal foil IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Z My first Gage R&R - Paper/Poly/Foil Material Bond Test, need help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 15
E Application of Foil to Enclosure (Recessed Connector) IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
R Seal Packaging - Burst and Leak Specifications for a Foil Seal applied to a PTFE well Manufacturing and Related Processes 4
P ASTM F2054 specification for burst testing on sealed foil & laminate pouch Manufacturing and Related Processes 3
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
M API 4F/7K/8C Design Package Validation Oil and Gas Industry Standards and Regulations 1
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
N Post Market Surveillance Package Example Wanted ISO 13485:2016 - Medical Device Quality Management Systems 1
H Re-labelling in IVDD - Re-label two products and package them as one CE Marking (Conformité Européene) / CB Scheme 5
M UDI-PI on a package that contains more devices EU Medical Device Regulations 3
M Identical Sales Package in Different Countries Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
F Adding a medical device in another medical device package EU Medical Device Regulations 2
M Package Integrity Test ASTM F 2096 or ASTM 1929 Quality Assurance and Compliance Software Tools and Solutions 1
M Medical device package insert in EU and USA Japan Medical Device Regulations 2
M Switching (Migrating) to a new QMS Software Package Document Control Systems, Procedures, Forms and Templates 10
J Referencing Medical Device in FDA records - Package contains several other components Other Medical Device Regulations World-Wide 1
S Package performance testing for non-sterile Hydrogels US Food and Drug Administration (FDA) 1
E IVD Vials - If we CE Mark a kit's package, do we also have to CE Mark the vials? CE Marking (Conformité Européene) / CB Scheme 4
S "Update" the PPAP Package after Mass Production Commences APQP and PPAP 2
shimonv Packaging Validation for Non-Sterile Package EU Medical Device Regulations 5
Pmarszal GUDID Packaging - Two part package Other US Medical Device Regulations 5
A API (American Petroleum Institute) Design Package Content Requirements Oil and Gas Industry Standards and Regulations 1
P ASTM-F2096 Medical Package Testing Various Other Specifications, Standards, and related Requirements 1
S Package Storage Direction in an I.T. Warehouse ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A JEDEC Std to use as reference for a package of size of 29x29mm with 0.8mm ball pitch Design and Development of Products and Processes 6
R How to go about package validation on a class II, non-sterile device US Food and Drug Administration (FDA) 4
B In-Process Sampling Plan for a Secondary Package Adjustment Process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
D Incentive Package for obtaining ISO 14001 Certification ISO 14001:2015 Specific Discussions 6
H Package Integrity Testing Acceptance Criteria ISO 13485:2016 - Medical Device Quality Management Systems 3
S AS9100C Complete Internal Audit Software Package Recommendations Quality Assurance and Compliance Software Tools and Solutions 13
R What is PSW - Statistical Process Package + Level 5 APQP and PPAP 7
J MOT (Traveler/Router) Software Package Help Quality Assurance and Compliance Software Tools and Solutions 3
K Can anyone recommend a PPAP software package? Quality Assurance and Compliance Software Tools and Solutions 11
C Lean Sigma Manufacturing Handoff Package Contents FMEA and Control Plans 8
Q Faking Data - Refusing to sign Falsified PPAP Submission package Nonconformance and Corrective Action 27
M "Streamlining Package Seal Validation" - I'm looking for this article reference Book, Video, Blog and Web Site Reviews and Recommendations 2
M How to validate a Dye Test method used to evaluate Package Integrity Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 8
D Packaging Addition - Non-sterile barrier to protect the whole package 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12
V Issue: Suppliers charge for complete Level III PPAP package - Heat Treated Parts APQP and PPAP 16
J Cpk & Ppk - Reviewing a PPAP Package - Some questions Statistical Analysis Tools, Techniques and SPC 8
G Various ?QMS? packages on the market - Which software package? Quality Assurance and Compliance Software Tools and Solutions 35
M MRP/QMS Software Package to replace our current Paper QMS - Help Quality Assurance and Compliance Software Tools and Solutions 4
J What is a Standard Level IV QA Package General Measurement Device and Calibration Topics 1
F Sterile Barrier Package (Tyvek Pouch) Validation Question ISO 13485:2016 - Medical Device Quality Management Systems 7
H Surgical Sealant Package Integrity Test for Glass Vial Filled Product Other Medical Device Related Standards 3
jasonb067 Testing to ISO 8573 (Compressed Air Package) Classification 4, Paragraph 6.1 Other ISO and International Standards and European Regulations 8
S Does Package Validation required for Service Parts Packaging Carton Box? ISO 13485:2016 - Medical Device Quality Management Systems 1
T Electronic Package inserts EU Medical Device Regulations 6
M APQP Timing Plan Details and APQP Package Contents (e.g.: floor plan) - Batch Mfg. APQP and PPAP 5

Similar threads

Top Bottom