MEMO

Change Control for Functionally Equivalent

Like-For-Like Change MEMOCPR22056
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Domino Printer for Packaging Machine WC-179 & WC-228

Copan Industries
Change Control for Functionally Equivalent
Like-For-Like Change
Domino Printer for Packaging Machine
WC-179 & WC-228

SUMMARY

1. Purpose.......................................................................................................................................... 6
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Domino Printer for Packaging Machine WC-179 & WC-228

2. Background................................................................................................................................... 7

3. Scope.............................................................................................................................................. 7

4. Responsibility................................................................................................................................ 9

5. Sampling & Testing Plan.............................................................................................................. 9

6. General Instructions................................................................................................................... 10

7. Record Form List........................................................................................................................ 11

8. Approvals..................................................................................................................................... 11

Rev. Date Activities Description

00 2022/06/15 Issue new revision

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1. Purpose

The purpose of this MEMO is to describe the instructions required to perform a risk/impact evaluation of
Domino printer change on Colimatic Packaging Machines WC-179 and WC-228; located on facilities of
Copan Industries at Aguadilla, Puerto Rico. It is in order to maintain operations without any impact on
packaging process validated.

2. Background

Colimatic Packaging Machine WC-179 and WC-228 were validated on 2021/10/26 and 2021/02/16,
respectively. Table 1 summarize the information of printer component validated by machine, refer to
Appendix I.

Table 1 Domino Printer Validated by Colimatic Machine

Printer Domino Information WC-179 WC-228
Manufacturer Domino UK Ltd. Domino UK Ltd.
Model A520i A520i
Serial Number AST000124713 AST000124715
V – A – Hz * 100/240V – 4A – 50/60 Hz 100/240V – 4A – 50/60 Hz
* V (Voltage), A (Amperage) and Hz (Hertz).

Both printers are used on packaging process to print the variable data related to production order. There
are: code, batch number, lot number and expiration date.

The Domino printers listed on Table 1 have the manual Part No. EDP002568/5. This document contains
basic operation instructions for the Domino A-Series i-Tech ink jet printers. This A-Series is a
continuous ink jet printer that uses either 1 or 2 jets (depending on configuration) for printing on a user
supplied substrate. The intended use of this printers is for printing variable data on manufacturing
production lines. For A420i and A520i models, i-Tech module replacement will vary according to the
type specified. For these printers, the operation of equipment is by push bottom access.

In other hand, a minor change will be proposed by Technician Department to obtain same model of
Domino Printer presented on Table 1 but with an upgrade related to i-Tech module. These new Domino
printers have the manual Part No. EPT006508. This document contains instructions for use in the
operation and repair of Domino A-Series i-Tech printers equipped with touchscreen displays. For these
printers, the operation of equipment is by touchscreen access. For A420i and A520i model
specifications follows the same established on manual Part No. EDP002568/5.

3. Scope
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Domino Printer for Packaging Machine WC-179 & WC-228

This evaluation will be applicable to Domino printers installed on Colimatic Packaging Machines WC-
179 and WC-228 and the new Domino printers acquired. Refer to Table 2 for details of new Domino
printers.

Table 2 New Domino Printers Acquired by Colimatic Machine

Printer Domino Information WC-179 WC-228
Manufacturer Domino UK Ltd. Domino UK Ltd.
Model A520i A520i
Serial Number AST000125555 AST000125497
V – A – Hz * 100/240V – 4A – 50/60 Hz 100/240V – 4A – 50/60 Hz
* V (Voltage), A (Amperage) and Hz (Hertz).

In order to identify the risks or consequences of this change, the following is considered as decision-
making tool related to Form-Fit-Function-Failure, refer to Figure 1:
Figure 1 Like-for-Like Decision-Making Tool

Guidance and tools are required to ensure decisions taken are consistent with company polices regardless
of the decision-makers background, experience, or shift pattern. It is expected the Like-for-Like
decision-making tool, if used when accessing equipment changes, will reduce any hidden risk to product
quality, patient’s safety, and business. A comparative between current Domino printers with new
Domino printers will be performed according to like-for-like decision-making tool (refer to Figure 1).
For all test listed on this tool will be generated to collect the results after evaluation.
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4. Responsibility
Table 3: List of Responsibilities

Department Responsibilities
 Generate and approve this memo.
 Coordinate all activities.
 Execute applicable instructions described in this memo.
 Generate the testing forms.
Validation
 Perform the testing of all test samples.
 Record results in applicable forms.
 Complete and approve memo report.
 Share approved memo report with stakeholders.
 Provide user manual and specifications of Domino printers.
 Uninstall current Domino printers and install new Domino printers on WC-179
and WC-228, respectively.
Technical Services
 Provide preventive maintenance and spare parts evidence for new Domino
printers.
 Provide support as deemed necessary.
Safety  Perform the Safety Verification Test.
Supply Chain  Provide materials required for the assessment.
 Review/approve this memo prior to execution.
QA  Provide support as deemed necessary.
 Review/approve final memo report.

5. Sampling & Testing Plan

The sampling plan is established according to ISO 2859-1, General Inspection Level of II and AQL of
0.1. This As a result, the sample size per each AQL sampling inspection evaluation is 125 units. This
sample size will be applicable for all test considered in this verification.

The testing includes the following criteria:

 FORM:
o Equipment’s General Specifications Verification. To verify the shape (components integrated),
size (general dimensions), material of constructions, and condition of each printer model.

 FIT:
o Equipment’s Utility Specifications Verification. To verify the utilities required by printer,
including electrical, mechanical, pneumatic and/or software (when applicable).
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 FUNCTION:
o Sequence and Interlocks Verification. Use the SOP applicable for Colimatic Packaging
Machines WC-179 and WC-228 and user manuals provide by manufacturer to verify if is
applicable without any upgrade using the new Domino Printers.
o Use the sample plan established in this section to verify the variable data: code, batch number,
lot number and expiration date, as applicable by machine. Document the results on applicable
form.
o Safety Verification Test. To verify that the system is equipped with all necessary safety
devices required by the applicable current Law and Copan safety rules. This test will be
performed by safety representative.
o Preventive Maintenance Verification. Request to Technical Department the preventive
maintenance and spare list for new Domino printers to ensure that this equipment is
contemplate on maintenance program of Copan.

 FAILURE
o Black Out Test. To verify the correct operation of the control system in case of power failure.

6. General Instructions
6.1. Request to the Technical Services department the user manual for new Domino printers. Verify the
general specifications on Form 1.
6.2.
Submit to Supply Chain a request for the materials needed to perform this evaluation. Record material
information in Form No 1.
6.2 Request to the Technical Service department the removal of the Chevron sealing plates and the
installation of the Flat sealing plates. Document the information required in Form No 2.
6.3 Setup machine parameters at low operational settings and record values in Form No 3.
6.4 Start the run at low machine parameters. Collect and label samples at the beginning, middle and
end of the low limit run. Document information required in Form No 4.
6.5 After completion of the low limit run, setup machine parameters at high operational settings and
record values in Form No 3.
6.6 Start the run at high machine parameters. Collect and label samples at the beginning, middle and
end of the high limit run. Document information required in Form No 4.
6.7 After completion of the high limit run, request the Technical Service department to remove Flat
sealing plates and reinstall the Chevron sealing plates. Then, run on nominal parameters to
maintain the current validated state. Document the information required in Form No 2.
6.8 Perform the testing of before sterilization samples, for both run and record the result in Forms No
4, 5 and 6.
6.9 Coordinate the shipment the applicable samples to corresponding sterilization supplier.
6.10 Once samples are received from sterilization supplier, perform after sterilization testing. Record
results in Forms No 4, 5 and 6.
6.11 Generate a final report summarizing the results obtained.
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7. Record Form List

Table 4: List of Forms

Record Form Title

Form 1 Equipment’s General Specifications Verification
Form 2 Equipment’s Utility Specifications Verification
Form 3 Sequence and Interlocks Verification
Form 4 Variable Data Verification
Form 5 Safety Verification Test
Form 6 Preventive Maintenance Verification
Form 7 Black Out Test

8. Approvals

Xavier J. Aguilar
Name Date Significance: I have generated and
performed the contents of the
Validation Engineer Report.
Qualification

Alexis Rodríguez
Name Date Significance: I have performed and
reviewed the contents of the
Technical Services Supervisor Report.
Qualification
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Nelson Valentín
Name Date Significance: I have generated and
reviewed the contents of the
Engineer Manager Report.
Qualification

Elizabeth Quinones
Name Date Significance: I have reviewed and
approved the contents of the Report.
Quality Assurance Manager
Qualification