Heat Sealers Upper and lower limit setting during OQ for Heat Sealer

#1
Hi there, we recently bought 4 Heat Sealer where pressure and speed are can not be changed and therefore only the temperature is going to be tested as part of OQ.

However I have the following question:

The Manual for the Sealers say that there is an internal deviation from the set point of +/-5°C. Also from the calibration certificate the accuracy of the heating element is +/-1%.

I am trying to set the upper and the lower limit that we need to validate the new sealers so do I set the upper and lower limit from the mean of +/-1% or do I set the upper and lower limit from the mean of +/-5°C plus +/-1%.

Thanks a lot.

Regards
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
R MSA studies for Heat Treatment Equipment Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
K Calculating Heat Dissipation Manufacturing and Related Processes 1
B API Q1 5.7.1.5 Process Validation - Machining, heat treating, Manganese Phosphate and Zinc Plating Manufacturing and Related Processes 2
G Heat Number on CofC - Stainless steel tube Manufacturing and Related Processes 2
K Moist Heat Sterilization worldwide Requirements and Regulations Other Medical Device Regulations World-Wide 1
D Minor non-conformance for not receiving a CofC from a heat treater Manufacturing and Related Processes 10
T Heat treat test dimple Manufacturing and Related Processes 3
X Heat Treat - Verifying mechanical properties on heat treated material per the ASTM Manufacturing and Related Processes 6
Ron Rompen The Effect of Heat on Production and Quality Human Factors and Ergonomics in Engineering 14
S Performing PQ on a Small (tabletop) Air Heat Treating Oven ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M API 6D-2014 24th Ed. Pto 6.10 - Heat Treatment Equipment Qualifications Oil and Gas Industry Standards and Regulations 4
H Standards to use for Propylene Glycol Heat/Cooler Fluid in a Device RoHS, REACH, ELV, IMDS and Restricted Substances 2
C Practical use of Heat Input calculation for Manual MIG Welding Manufacturing and Related Processes 4
S Heat Treatment - Soaking time interpretation Manufacturing and Related Processes 5
S Industrial Aseptic Bag Heat Sealing Sampling and Qualification Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
elkel CQI 9 (Heat Treatment) Assessment Requirements - Company and Customer Requirements Customer and Company Specific Requirements 1
S Paperless Temperature Recorder for Temperature Surveys on Heat Treatment Ovens General Measurement Device and Calibration Topics 6
I AS9100 PPAP requirements for outside Heat Treat vendors/suppiers AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
G SPC in Heat Treatment Workshop Statistical Analysis Tools, Techniques and SPC 2
S AMS 2750E Heat Treat Furnace System Accuracy Test SAT Report question AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
S Heat Map ISO/TS 16949:2009 Clauses IATF 16949 - Automotive Quality Systems Standard 1
M AMS2770 Aluminum Heat Treat - Determining Soak Time Various Other Specifications, Standards, and related Requirements 1
S Thermal Sensitivity Testing - Heat Lamp - ILY - Increased blood circulation IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F Heat and Moisture Oxygen Port Changes Classification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
J ISO 17665-1 & 2 Review and approval of validation (of moist heat sterilizers) Other ISO and International Standards and European Regulations 3
Q Heat Treat Steel, Rockwell C - Variability in Complex Machined Shapes Manufacturing and Related Processes 7
M Who Stole our Nevada Heat Coffee Break and Water Cooler Discussions 7
J FAI for Heat Treated Details - Inco Parts Shrink AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
W IR Camera - Heat Survey of parts during dynamic testing General Measurement Device and Calibration Topics 5
P NADCAP Certified - Heat Treat Continuous Belt Driven Oven question AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
A NADCAP AC 7101/03 Heat Treatment Process Acceptance Tests AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
V Is there a Heat Treat certification that is required at PPAP? APQP and PPAP 4
R CQI-9 Heat Treat Assessment Services recommendations wanted IATF 16949 - Automotive Quality Systems Standard 3
V Is the CQI-9 Heat Treat Assessment performed by a 3rd Party Auditor APQP and PPAP 1
J CQI-9 Table E, 4.1 - Heat Treating Process Requirements Other ISO and International Standards and European Regulations 2
S Special Gages for Measuring Pre-Heat Treat Thread Size Measurement Uncertainty (MU) 3
R Fuses that in series with each supply lead are only housed by Heat Shrink Tubing IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
J Impact of 17-4 PH Heat Treating the same material twice Manufacturing and Related Processes 7
V CQI-9 Heat Treat System Assessment Other ISO and International Standards and European Regulations 11
V Issue: Suppliers charge for complete Level III PPAP package - Heat Treated Parts APQP and PPAP 16
V What should I require of a Heat Treat PPAP? Surface Hardness per SAE J664 APQP and PPAP 1
R CQI-9 Heat Treatment Process Table C question IATF 16949 - Automotive Quality Systems Standard 3
K Heat Treatment (Softening) on Cast Iron before it can be drilled to form Thread? Manufacturing and Related Processes 4
Sam Lazzara Bar Sealer vs. Impulse Sealer for Medical Pouch Heat Sealing Qualification and Validation (including 21 CFR Part 11) 4
S Applied Part Classification for Mattress for Radiant Heat Warmer IEC 60601 - Medical Electrical Equipment Safety Standards Series 19
R A way to verify 7075 T0 Aluminum has been successfully Heat Treated to T6 Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
L Plug Gages and Tapered Holes - Compensation for Heat Treat Distortion General Measurement Device and Calibration Topics 1
L Heat Treat Calibration Records - API 6a sec 5.8 and annex M Requirements Oil and Gas Industry Standards and Regulations 3
D Will just Heat and Humidity be Adequate to Simulate EtO Sterilization? Design and Development of Products and Processes 2
S Heat Exchanger Fabrication Question Manufacturing and Related Processes 2
Similar threads


















































Top Bottom