G-102

Equipment Profiles

Section G — Equipment Revision 4 6 pages

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1.0 Purpose

This procedure defines the process of creating and maintaining records on each piece of

process equipment or testing equipment used at Ion Labs, Inc.

2.0 Scope

This procedure applies to all process equipment and testing equipment in use at Ion Labs, Inc.

3.0 Responsibility

3.1 It is the responsibility of Maintenance and/or Engineering Management or designee to

complete equipment profiles for equipment within their department and to submit it to

DC.

3.2 It is the responsibility of DC to assign asset numbers and to maintain the current master

equipment list and all equipment profiles.

3.3 It is the responsibility of Maintenance and/or R&D to initiate form G-103-F1

Installation and Operational Qualification (OQ) Checklist (if applicable) after the
equipment profile has been approved.

4.0 Definitions

4.1 PM — Preventative Maintenance

4.2 DC — Document Control

4.3 QC — Quality Control

5.0 References

“N

[SOP

Standard Operating Procedure SOP No Rev ee a
Equipment Profiles G-102 4 age 2 of 5

5.1 G-103, SOP, Qualification of Equipment

5.2. G-201, SOP, Calibration Program

5.3. G-102-F1, Form, Equipment Profile

5.4 G-103-F1, Form, Installation and Operational Qualification (IOQ) Checklist

5D C-502, SOP, Document Storage, Retention, and Destruction

6.0 Procedure

6.1 Equipment profiles will be completed for each piece of equipment on the master

equipment list.

6.1.1 Form G-102-F1 Equipment Profile lists the primary identifying information

about the equipment:

6.1.1.1 Ion Asset Number — each piece of equipment will be assigned a unique

sequential asset number consisting of the letters ION, followed by a

four digit sequential number (e.g. ION-0001)

6.1.1.2 Equipment Description

6.1.1.3. Manufacturer

6.1.1.4 Model Number (if available)

6.1.1.5 Serial Number (if available)

6.1.1.6 Purchase Order Number

6.1.1.7 Date of Receipt of Equipment

6.1.1.8 Equipment Location

Note: Legacy equipment may not have all of the purchasing

information. Document “Legacy Equipment” if not available.

[SOP

Standard Operating Procedure SOP No Rev
G-102 Page 3 of 5
Equipment Profiles

6.1.1.9 Calibration Requirements and Recommended Frequency

6.1.1.10 Maintenance Requirements and Recommended Frequency

6.1.1.11 Name and Date of Employee Completing the Profile

OZ Quality will review for completion and approve the completed profile.

6.1.3 A copy of any literature or software, including manuals or bulletins that
accompany the equipment, will be filed with the equipment profile if possible.

6.1.4 Original machine manuals will be filed in maintenance for ease of use.

6.1.5 Once approved, all information will be entered by DC into the Master

Equipment List.

6.2 Upon approval of the equipment profile:

6.2.1 DC will submit a copy of the profile to QC Laboratory/Analytical Development
Management for inclusion in the Calibration Program (refer to SOP G-201

Calibration Program).

6.2.2 SD will submit a copy of the profile to the initiator to thatForm G-103-F1
Installation and Operational Qualification (IOQ) Checklist can be completed.

(refer to SOP G-103 Qualification of Equipment.

6.2.3 Once G-103-F1 Installation and Operational Qualification (IOQ) Checklist has

been finalized, it will be scanned and filed with the associated equipment
profile.

6.3 When a piece of equipment that has an asset number assigned to it is removed from
service, DC must be alerted so that the item may be marked as “Out of Service” on the

master equipment list.

[SOP

Standard Operating Procedure SOP No Rev
G-102 Page 4 of 5
Equipment Profiles

6.4 Equipment Types that require an Asset Number

6.4.1 The following types of equipment require an asset number before they can be

used. There may be other equipment types not listed below that must also
comply with this procedure.

6.4.1.1 Manufacturing Equipment

6.4.1.2 Packaging Equipment

6.4.1.3 Mobile Fans

6.4.1.4 Hygrometers and Thermometers

6.4.1.5 Scales

6.4.1.6 Test and Calibration Pieces

6.4.1.7 Blender Magnets

6.4.1.8 QC Laboratory Equipment

6.4.1.9 Shop Vacuums

6.4.1.10 Dehumidifiers

6.4.1.11 Humidifiers

6.4.1.12 Sensors

6.5 Documentation Requirements

6.5.1 Documents will be maintained following SOP C-502 Document Storage,
Retention, and Destruction.

[SOP

Standard Operating Procedure SOP No | Rev oe
Equi. pment Profiles o“i e ’ ag:es 0

7.0 Revision History

| Rev | Date | Description of Changes | CCR # | By |
|-----|----------|------------------------|-------|----|
| 0 | 04/27/10 | New - - 03/25/13 Changed SOP format and number. Updated SOP. 13-197 I. Iichev Obsoleted G-102-F2, C-102-F3. Included G-101 in G-102. 2 eos Clarified SOP to accurately reflect the current process. ieee D2 EOPp | - | - |
| 3 | 02/05/19 | Scheduled review: updated calibration program responsibility. Added additional reference. | 19-0124 | Runs |
| 4 | 04/06/22 | Scheduled review: Updated responsibilities. Changed logo. Added CC- list of equipment that requires asset numbers. | 22-0161 | K. Burris |

[SOP

IANLABS Equipment Profile
Form
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* G-102-F1 CCR No. CC-22-0161 Rev1810n 4

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Comments

Completed By Datee
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Approved By (Quality) Date°
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