Request a consultation

Guide

Tray-sealing qualification and process evidence

An Atlas Vac sealer controls and records the sealing process. Qualifying a package and its sealing process is a separate body of work, carried out by your organization and built on that evidence. This guide explains where one ends and the other begins.

Three levels of evidence

Equipment, records, and the package itself

Each level answers a different question and is established by a different party. Treating one as proof of another is the most common source of confusion in tray-sealing qualification.

  1. Equipment

    Controls, safeguards and calibration of the sealer’s instruments.

    Supported by Atlas Vac calibration and IQ/OQ assistance

  2. Records

    Cycle-by-cycle process data, audit trail and alarms captured by the sealer.

    Provided by the sealer as configured

  3. Package and process

    Evidence that the sealed package meets the customer’s requirements.

    Defined and owned by the customer’s quality system

Explanatory diagram

The boundary

Each level supports the next. None substitutes for another.

  • Calibration of the sealer does not demonstrate package validation.
  • Recorded process data does not prove package compliance.
  • Package and process qualification remains the responsibility of the customer’s organization.

Process variables

Temperature, dwell and pressure are inputs. Force is an observation.

The sealer sets, holds and records its inputs. Which values a package requires is established by the process owner for that package.

  • Temperature

    Input · controlled

    Set and controlled per recipe, with fail-safe alarms. Thermocouples carry calibration connectors.

    For the process owner

    Which temperature window does the package require?

  • Dwell

    Input · controlled

    Seal time is set per recipe and recorded with every cycle.

    For the process owner

    Which seal time does the package require?

  • Air pressure

    Input · regulated

    Regulated manually as standard, or by closed-loop control with the Process Control option, within password-set limits.

    For the process owner

    Which pressure range is acceptable?

  • Force

    Observation · measured

    Direct Force Sensing reads lb‑f on every stroke. Standard on the All Electric; on pneumatic models a reference reading, not closed-loop control.

    1522, 1830S and 1830 Dual requirements To be confirmed

    For the process owner

    Is force to be specified in the sealing protocol?

No settings, windows or acceptance limits are given here. They are established for each package.

Controls and options

Records

What the sealer records, and what it does not show

Three records are kept for every cycle. They support review and investigation within your quality system.

  • Process record

    • Time, temperature and pressure
    • Date, time and cycle count
    • Recipe, product, lot and UDI

  • Audit Trail

    • Recipe creation, loading, deletion and edits
    • Calibration changes and access events
    • Username, when the operator is signed in

  • Alarm record

    • The alarm and the parameter that triggered it
    • Cycle count at the alarm

Limits

Operator identification is optional, so not every event carries an operator name.

Records support review and investigation; they do not prove package compliance.

Records and data

Atlas Vac support

Calibration and qualification assistance

Atlas Vac supports the equipment level of evidence for the sealers it designs and builds.

Calibration

Atlas Vac provides OEM calibration services for its own tray sealers.

  • NIST-traceable instruments
  • Instrument documents supplied with each calibration report
  • Annual calibration offered for each installed sealer
  • Atlas Vac is not an ISO 17025 certified laboratory

IQ and OQ

Atlas Vac field service technicians provide IQ and OQ services on Atlas Vac sealers.

  • Scope agreed with each customer for each project
  • Performance or process qualification of the customer’s package is not an Atlas Vac service

Training

In-house personnel can be trained in calibration protocols, troubleshooting and repairs. Calibration data sheets and protocols are available to registered users in Technical Documents.

Before a technical discussion

Questions to settle

Useful if you have it. Atlas Vac works with what is known and identifies what remains to be settled.

Known assumptions
The package, tooling, loading method and utilities.
Control and measurement
Which variables must be controlled, which must be measured, and whether force is to be specified.
Records
Which records, identifiers and access levels the quality system requires.
Support scope
The calibration, IQ/OQ assistance and training required, and the sealer configuration they apply to.
Customer responsibility
Which package and process evidence the organization will establish itself.
Service and calibration Discuss your evidence needs

Evidence and support

Discuss your evidence needs

Atlas Vac engineering and field service review the configuration, records and support scope with your quality and process teams.

Useful if you have it

Model and serial number, or intended configuration · Records required · Support scope required

Request a consultation +1 (513) 407-3513
Address
Atlas Vac Machine, LLC
9150 Reading Rd
Cincinnati, OH 45215, USA
Phone and email
(513) 407-3513
sales@atlasvac.com
Hours
Mon–Fri 08:00 am – 05:30 pm
Saturday by appointment
Sunday closed