G-201

Calibration Program

Section G — Equipment Revision 6 14 pages

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1.0 Purpose

The purpose of this procedure is to describe the process for the identification, scheduling, and
logging of equipment to be calibrated.

2.0 Scope

This procedure applies to all equipment maintained by Ion Labs, Inc. requiring calibration. This
procedure describes general calibration requirements and is superseded by instrument/machine

calibration requirements described in its specific procedure. Furthermore, analytical instrument
calibrations are governed by SOP G-208 Analytical Calibration and Equipment Control and

any calibration requirements described in that procedure supersede these instructions.

3.0 Responsibility

cm It is the responsibility of Analytical Development Management to align this procedure

with current practices and to delegate and oversee management of the program.

3.2 It is the responsibility of Maintenance to submit operational equipment profiles to

document control, and the Metrologist, or designee, for new analytical equipment as
outlined in SOP G-208, Analytical Calibration and Equipment Control.

Due It is the responsibility of Quality to oversee and ensure compliance to this procedure for

all Quality Personnel.

3.4 It is the responsibility of Production to oversee and ensure compliance to this procedure

for all Production Personnel.

3.5 It is the responsibility of the QC Laboratory and Metrologist to oversee and ensure

compliance to this procedure for all QC Laboratory Personnel.

[SOP

Standard Operating Procedure SOP No | Rev Baseman
Calibration Program G-201 6 age 20

3.6 Any qualified individual may arrange or execute calibrations, place calibration stickers
on equipment, however, logging and maintaining equipment calibration schedules is

performed by the Metrologist or designee.

4.0 Definitions

4.1 Calibration — Comparison of equipment performance against a traceable standard or

certified instrument to detect, correlate, report or eliminate by adjustment, any variation
in the accuracy of the item being compared

4.2 Certification — Written verification that the device operates within applicable
specifications

4.3 Verification — An equipment check against a standard to confirm that the equipment is
in a state of calibration (or operating as designed where applicable). The equipment can

remain in operation if the calibration is verified as within specification for a period not

to exceed the recommended verification interval.

4.4 Due Date — The month the piece of equipment needs to be calibrated or verified.

Equipment due in a specific month needs to be calibrated or verified by the last day of
the month of the next calibration due date. The instrument may be used within that

month. The equipment is not to be used on or after the first day of the next month
without a certificate of calibration in effect. In extreme circumstances, an item is used

outside its calibration date. In that case, the results gained from the equipment may be

deemed valid if the item upon next calibration has its “as found” results within
specifications.

4.5 QC — Quality Control

4.6 QA — Quality Assurance

4.7 AD — Analytical Development

4.8 PM — Preventative Maintenance

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Standard Operating Procedure SOP No | Rev a EaCRNOEAT
Calibration Program G-201 6 age 3 0

4.9 OQ — Operational Qualification

4.10 PQ — Performance Qualification

4.11 Asset Essentials — a cloud-based software that enables you to assign and track the
progress of all maintenance activities, manage equipment uptime and reliability. For

calibration purposes, Asset Essentials is utilized for scheduling only.

5.0 References

dul G-102-F1, Form, Equipment Profile

Die G-201-F1, Form, Calibration Certificate

5:3 G-201-F2, Form, Completed Calibration Log

5.4 QS-114, SOP, Risk Management and Risk Analysis

3.5 G-208, SOP, Analytical Calibration and Equipment Control

5.6 C-502, SOP, Record Storage, Retention, and Destruction

5.7 ANSI/NCSL Z540.3-2006; ISO 10012-1, ISO/IEC Guide 25

6.0 Procedure

6.1 Asset Essentials:

6.1.1 New assets that require calibration are logged into Asset Essentials, typically

initiated by form G-102-F1 Equipment Profile.

6.1.2 Information entered into Asset Essentials:

6.1.2.1 Description of Equipment

6.1.2.2 Ion Asset Number

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Standard Operating Procedure SOP No | Rev
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Calibration Program
6.1.2.3. Location of equipment (if needed)

6.1.2.4 Calibration Due Date

6.1.3 Current Assets already cataloged in Asset Essentials are amended as calibrations
are completed and new calibration due dates are assigned.

6.1.4 Assets are typically cataloged/ grouped by calibration due date month in Asset
Essentials.

Monthly, Asset Essentials will generate a work order for all required
calibrations due in that month. This work order is emailed to the metrologist or

designee for completion.

6.1.6 Upon successful completion of calibrations, the work order can either be closed

or amended with a new due date in Asset Essentials.

6.1.7 Form G-201-F2 Equipment Calibration Log will be completed as needed to log
calibration information for equipment. This form will be cataloged by month/

year and maintained in a binder or equivalent storage format. The form will
include the following information:

6.1.7.1 Month

6.1.7.2 Year

6.1.7.3 Ion Asset #

6.1.7.4 Description

6.1.7.5 Calibration type - Temperature, Humidity, Weight, RPM, etc.

6.1.7.6 Frequency - Weekly, Monthly, Biannual, Annual, etc.

6.1.7.7 Internal or External calibration

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Standard Operating Procedure SOP No | Rev
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Calibration Program

6.1.7.8 Date of calibration

6.1.7.9 Logged by/Date

6.1.7.10 Page

6.1.8 Each sheet of form G-201-F2 Equipment Calibration Log can correspond only

to one month and one year. At the end of each month, the unused part of the
form will be lined out, initialed and dated.

6.1.9 Stored within each monthly section is a calibration certificate for every piece of
equipment tested during that specific month.

6.1.9.1 External calibration certificates will be labeled with the Ion# and/ or

equipment serial number at the top of each page for tracking purposes,
if not already present on certificate.

6.1.9.2 The calibration due date on the external calibration certificate should
reflect at least the minimum frequency specified by the Ion Labs

calibration/verification program otherwise the Ion Labs frequency
supersedes the vendor frequency. Any changes made to the calibration

due date on the certificate must be signed or initialed.

6.1.10 Equipment that either does not pass or has an expired calibration can either be
removed from service and obsoleted or sent for repair. If repaired, a new

calibration must be completed prior to placing back into service.

6.1.11 For new equipment accompanied by a calibration certificate and calibrated by

the manufacturer, the manufacturer due date will supersede Ion Labs Frequency
specifications. For subsequent calibration verifications, the Ion Labs frequency

will be used.

6.1.12 Certificates for scales, weights, thermometers, and calipers are retained by

metrology and are also referenced in all equipment profiles in Asset Essentials.

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Calibration Program
6.2 Execution of the Calibration Program

6.2.1 The program will be overseen by the Metrologist or designee.

6.2.2 Form G-201-F2 Equipment Calibration Log will be filled out and closed
monthly.

6.2.3 PM work orders for analytical equipment in production will be generated by
Asset Essentials and performed by the metrologist or designee. Analytical

equipment in production includes: Friabilator and hardness instruments used for
in-process product evaluation.

6.2.4 Purchase orders will be prepared from quotes for equipment to be tested by an

external calibration service.

6.2.5 All calibration vendors must be approved by QA or Metrology before use.

6.2.6 For equipment calibrated by external sources, a copy of the calibration
certificate will be provided by the service provider and forwarded the

metrologist or designee for filing.

6.2.7 If applicable, Calibration/PM performed by external vendors must meet any

requirements for calibration stated in the equipment’s profile and/or SOP.

6.2.8 A qualified individual, preferable the metrologist, will review all external

calibration certificates and write Ion# and/ or serial number at the top of the

certificate, if not already present.

6.2.9 All certificates received externally will contain a decision as to the condition “‘as

left”, completed by provider. This decision may include a “Pass/ Fail”
statement or an “In Tolerance” statement.

6.2.9.1 External service providers used for calibration activities must provide
this decision statement.

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Standard Operating Procedure SOP No | Rev ee
Calibration Program G-201 6 age 7 0

6.2.10 For in-house calibrations, Form G-201-F1 Calibration Certificate with the Ion#

and description listed will be issued to the person who completes the calibration.

6.2.11 The designated person will record all appropriate information about the
calibration on Form G-201-F1 Calibration Certificate and the form along with

any corresponding paperwork will be returned to the metrologist or designee.

6.2.12 Completed internal forms will be reviewed by qualified personnel for final

approval.

6.3 Establishing the Frequency of Calibration

6.3.1 The calibration frequencies listed in Attachment 1 Equipment Calibration

Frequency Table, are minimum Ion Labs frequency recommendations.
Deviations from the table for specific pieces of equipment may be justified by

review of manufacturer's documentation and/or previous certifications.

6.3.2 Early calibrations are permissible. The calibration schedule will reset beginning

from the latest calibration date.

6.3.3. Certain equipment (Dickson One Temperature/ Humidity Sensors, Digital

Temperature and Humidity Monitor, Conductivity meter, Jumbo Timer etc.) will
be replaced after factory certification is expired. The integrity of the metal

detector testing balls, rods and sticks will be checked every year to ensure no

rusting and chipping of the metal wrapped inside. If they are without defect,
they may be used indefinitely.

6.4 Calibration Stickers

6.4.1 Each piece of calibrated equipment will be marked with a sticker indicating its

calibration status.

6.4.2 Internally placed stickers will indicate at minimum:

6.4.2.1 ION ID#

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Standard Operating Procedure SOP No | Rev
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Calibration Program
6.4.2.2 The initials of the person conducting the calibration, or applying

the sticker.

6.4.2.3 The date of the calibration (MM-DD-YY)

6.4.2.4 The due date for the next calibration (MM-YY)

6.4.3. Externally completed calibrations will still be tagged using internal Ion
calibration stickers for consistency.

6.4.3.1 External company stickers may also be present on calibrated
equipment in conjunction with Ion stickers.

6.5 Failed Calibration

6.5.1 A piece of equipment that does not meet its calibration requirements will be

removed from service and logged as per Section 6.1.8.

6.5.2 If the equipment is serviceable an external calibration/repair service will repair
and recertify the piece of equipment before returning to service.

6.5.3. A"Do Not Use" placard will be affixed to all pieces of equipment that cannot be
internally verified and the sticker will only be removed after it has been repaired

and recertified by an approved vendor.

6.6 Failed as Found Calibration

6.6.1 If equipment does not meet its as found specification an investigation/risk
assessment should be performed as per QS-114 Risk Management and Risk

Analysis to determine its effect.

6.6.2 Any instrument specific procedure instructions supersede this guidance.

6.6.3 Any existing processes can be used for the investigation/risk assessment as well.

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Standard Operating Procedure SOP No Rev
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Calibration Program

6.6.4 Ifthe effect is minimal, the calibration certificate may be used to document any
risks.

6.7 Calibration Standards

6.7.1 Reference standards used for internal calibrations must be calibrated or verified

in compliance with ANSI/NCSL Z540.3-2006; ISO 10012-1 and/or ISO/IEC
Guide 25 using NIST traceable standards or standards derived from accepted

values of naturally occurring physical constants by an external service or source.

The calibration period of these items are set by the service and may not be
extended beyond the period indicated on their certificate.

6.7.2 Standards used for any equipment calibration will be captured as part of the
calibration paperwork.

6.7.2.1 Applicable C of A’s or certificates of calibration for standards will be
maintained with each piece of equipment for each calibration.

6.8 Document Retention

6.8.1 All documents will be maintained following C-502 Record Storage, Retention,

and Destruction.

[SOP

Standard Operating Procedure SOP No Rev
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Calibration Program

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 05/17/10 | New : - | - | - |
| 1 | 04/01/13 | Changed the SOP format & number, changed forms number : - Restructured Calibration Program. Realigned responsibilities. | - | - |
| 2 | 11/05/13 | . Improved clarity of the process. Added a Master Equipment List (electronic). Reorganized forms G-201-F1-F2-F3. Updated SOP format. Realigned responsibilities. Consolidated forms G-201-F1, G-201-F3. Added electronic spreadsheet, 3 Sh ORNS Calibration Schedule/Equipment List. Added document retention te-O022 Nichane time. Adjusted calibration frequencies for scales and weights. | 13-1013 | B. Johns |
| 4 | 04/04/17 | Add metal detector test kits and thermal and humidity monitor to program | 16-1120 | N. Zhang |
| 5 | 11/10/21 | Updated to reflect current processes. As found out of specification CC- report requires actions, Changed form numbers. Update to add Asset Essentials as a scheduling program. Updated to | 21-0088 | J. Maignan |
| 6 | 12/08/22 | reflect a metrologist. Updated to reflect current process and CC- practices. | 22-0466 | J. Sassman |

8.0 Attachments

8.1 Attachment 1 — Equipment Calibration Frequency Table

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Standard Operating Procedure SOP No | Rev
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Calibration Program

ATTACHMENT 1 — EQUIPMENT CALIBRATION FREQUENCY TABLE

Scale / Balance 1 Year External

Hardness Tester 6 Months Internal / External

Digital Viscometer 1 Year Internal / External

Friability Tester 1 Year Internal / External

Melting Point Tester 6 Months Internal / External
i aaa coe Deco 1 Year Internal / External

Weight Standard 2 Years / 5 Years External

Weight Standard — Daily Use 1 Year External

Torque Tester 1 Year External

Vacuum 1 Year Internal / External

Caliper 1 Year Internal / External

Metal Detector 1 Year Internal / External

Tachometer 3 Years External

Gauge Block 5 Years External

Laboratory and Production Equipment Variable Internal / External

Timer 1 Year Internal / External

Pipette 6 Months External

Disintegration Tester 1 Year Internal / External

Miscellaneous Variable Internal / External

[SOP

Standard Operating Procedure SOP No | Rev Page Lf 11
Calibration Program G-201 6 age llo

ATTACHMENT 1 —- EQUIPMENT CALIBRATION FREQUENCY TABLE

Scale / Balance 1 Year External

Hardness Tester 6 Months Internal / External

Digital Viscometer 1 Year Internal / External

Friability Tester 1 Year Internal / External

Melting Point Tester 6 Months Internal / External

a aaa a inti, oak Device! 1 Year Internal / External

Weight Standard 2 Years / 5 Years External

Weight Standard — Daily Use 1 Year External

Torque Tester 1 Year External

Vacuum 1 Year Internal / External

Caliper 1 Year Internal / External

Metal Detector 1 Year Internal / External

Tachometer 3 Years External

Gauge Block 5 Years External

Laboratory and Production Equipment Variable Internal / External

Timer 1 Year Internal / External

Pipette 6 Months External

Disintegration Tester 1 Year Internal / External

Miscellaneous Variable Internal / External

[SOP

IAN LABS Calibration Certificate

Form: G-201-F1 CCR No. CC-22-0466 Revision: 1

Standard Specification

Unit of Measure
Test Reading

Tolerance Allowed (Range)

Minimum Allowed Reading
Maximum Allowed Reading

*In Tolerance As Found (Y/N)

In Tolerance As Left (Y/N)
* If “As Found” tolerance is N, an explanation and risk assessment is required. Assessment may be documented below or a reference to
another document may be listed below.

Determination (check one): O Pass O Fail

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