VALIDATION PROTOCOL

Date of Issue: Protocol No:

02.03.2016 PROTOCOL FOR VALIDATION OF QSP7/VP/PFS/1.0
Revision: 1.0 PNEUMATIC FOIL SEALER OF Page: 1 of 6
ANSiStim/ AuriStim/ P-STIM

Revision History

Revision No Date Description

1.0 02.03.2016 New release

Name, Signature & Date

Reviewed By Approved By

[C.M.JaiShri] [K.Murugesh]
02.03.2016 02.03.2016

DIPL Confidential
 VALIDATION PROTOCOL
Date of Issue: Protocol No:
02.03.2016 PROTOCOL FOR VALIDATION OF QSP7/VP/PFS/1.0
Revision: 1.0 PNEUMATIC FOIL SEALER OF Page: 2 of 6
ANSiStim/ AuriStim/ P-STIM

1.0 PURPOSE:

The purpose of this protocol is to establish the criteria for the validation of Pneumatic Foil
Sealer (Equipment Name & Number) used to seal the Needle Assembly and Product pack
of ANSiStim/ AuriStim/ P-Stim.

2.0 SCOPE:

The validation of Sealing processes is decisive in order to guarantee that the integrity of the
packaging system is always achieved and maintained up until utilization.

3.0 PACKAGING DESCRIPTION:

Here we describe the Packaging which will be sealed using Pneumatic Foil Sealer.
(i) Needle assembly - PVC Blister sealed with Tyvek paper.
(ii) Product packaging - PVC Blister pack sealed with PVC sheet.

4.0 GENERAL:

Process validation shall include, an Equipment qualification and a Performance

qualification of the equipment. Revalidation shall rely on the previous installation and
operational qualification. Datas obtained from the validation shall be used for
determination of tolerances for critical parameters.

5.0 EQUIPMENTS/ CONSUMABLES:

1. Needle Sealing Fixture

2. Product Sealing Fixture
3. Foil Sealer – Sealing Machine
4. Air Compressor

6.0 EQUIPMENT QUALIFICATION:

Equipment qualification will consist of Installation qualification and Operation

qualification.

6.1 Installation Qualification(IQ):

DyAnsys considers the Installation Qualification as the process of obtaining and
documenting evidence that equipment has been provided and installed in accordance with
their specifications. The drawings of the equipment installed shall be reviewed.

DIPL Confidential
 VALIDATION PROTOCOL
Date of Issue: Protocol No:
02.03.2016 PROTOCOL FOR VALIDATION OF QSP7/VP/PFS/1.0
Revision: 1.0 PNEUMATIC FOIL SEALER OF Page: 3 of 6
ANSiStim/ AuriStim/ P-STIM

6.1.1.Installation Qualification shall be performed & the following parameters has to be

considered during IQ.
- Installation conditions such as internal wiring, Power cord, Insulation if any, etc.,
- Main On/Off Switch condition.
- Main On/Off Indicator.
- Heater On/Off Switch condition.
- Timer Selector Switch Condition.
- Temperature holding Switch condition.
- Temperature Selector Switch Condition.
- Temperature auto cut-off Indicator.
- ON Switch
- OFF Switch
- Seal Holding time Indicator.
- Location of the machine / rigidity of the machine base.
- Equipment design features & drawing and user manuals (if applicable)
- Safety features
- Equipment Operating within the stated design parameters
- List of critical spare parts
- Environmental conditions such as cleanliness, temperature, humidity
- Operator training
- Procedure for IQ

6.1.2. Critical Parameters like Temperature, humidity to be monitored.

6.1.3. Established preventive maintenance and periodic cleaning schedule to be adhered.

6.2 Operational Qualification (OQ):

DyAnsys considers Operation Qualification as the process of obtaining and documenting

evidence that installed equipment operates within predetermined limits or capable of
delivering the specified process within defined tolerances when used in accordance with its
operational procedures.

6.2.1 During the operational Qualification the normative requirements of the Sealing range
must be determined. Operational Qualification shall be assured the product packing & the
sterile barrier packaging, that meet all defined requirements under all anticipated
conditions of manufacturing.

DIPL Confidential
 VALIDATION PROTOCOL
Date of Issue: Protocol No:
02.03.2016 PROTOCOL FOR VALIDATION OF QSP7/VP/PFS/1.0
Revision: 1.0 PNEUMATIC FOIL SEALER OF Page: 4 of 6
ANSiStim/ AuriStim/ P-STIM

6.2.2 In order to determine the parameters, limit values for the critical parameters shall be
fixed. Using this upper and lower limit values test shall be conducted and shall exhibit the
properties that meet predefined requirements. Part of validation, critical quality parameters
shall be verified like, proper sealing, any channels, puncture and material de-lamination.

Sealing strength shall be evaluated through Integrity test method (Dye penetration test as
per ASTM F1929.

6.2.4 Calibration:
Calibration status of all the instruments involved in Validation shall be reviewed and a
copy of the calibration reports shall be attached in the Validation Report.

Calibration shall be carried out as per the frequency defined in the Master list. Frequency
of the calibration, will be derived based on the recommendations from the manufacturer of
the equipment OR based on the factors like usage, criticality & general recommendations.

7.0 PERFORMANCE QUALIFICATION (PQ):

DyAnsys considers Performance Qualification as process of obtaining and documenting

evidence that the equipment as installed and operated in accordance with operational
processes, consistently performs in accordance with predetermined criteria and there by
yields products meeting its specifications.

7.1 Performance Qualification shall include

- The actual or simulated product

- Process parameters established in the Operational Qualification
- Verification of product/package requirements
- Assurance of process control and capability, wherever applicable.
- Process repeatability and reproducibility

7.2 Challenges to the process shall include conditions expected to be encountered during
manufacture.

7.3 Challenges to the process shall include at least three production runs with adequate
sampling to demonstrate variability with in a run and reproducibility between different
runs. The duration of a production run should account for process variables.

Performance Qualification report shall be attached with the Validation Report.

DIPL Confidential
 VALIDATION PROTOCOL
Date of Issue: Protocol No:
02.03.2016 PROTOCOL FOR VALIDATION OF QSP7/VP/PFS/1.0
Revision: 1.0 PNEUMATIC FOIL SEALER OF Page: 5 of 6
ANSiStim/ AuriStim/ P-STIM

8.0 FORMAL APPROVAL OF THE PROCESS VALIDATION:

8.1 Review and approval of the process validation shall be carried out and documented by
appropriate personnel. The documentation shall summarize and reference all protocols and
results and state conclusions regarding the validation status of the process.

8.2. Process validation shall be done with respect to the procedure QSP7.

9.0 ACCEPTANCE CRITERIA:

The following criteria are met as a result of validation.

9.1 The Seal leak test by dye penetration must be positive, i.e the dye solution
must not leak through the channels of the needle and product blister.

10.0 REVALIDATION:

Revalidation frequency of process validation shall be 12 months from the previous

validation in normal case. Incase of any changes are made to the equipment, product,
packaging materials for packaging process, which compromise the original validation and
affect the sterility, safety or efficacy of device / components.

The following shall be the list of possible chances that could affect the status of a validated
process.

- Raw material changes that would impact the process parameters

- Change in the equipment / new equipment
- Negative trends in quality or process control indicators.

The need for revalidation shall be evaluated and documented. If the situation does not
require that all aspects of the original validation be repeated, this revalidation shall not
have to be as extensive as the initial validation.

11.0 PACKAGING SYSTEM ASSEMBLY:

Incase of the sterile barrier packaging, the same shall be assembled under appropriate
environmental conditions with respect to the appropriate procedures.

DIPL Confidential
 VALIDATION PROTOCOL
Date of Issue: Protocol No:
02.03.2016 PROTOCOL FOR VALIDATION OF QSP7/VP/PFS/1.0
Revision: 1.0 PNEUMATIC FOIL SEALER OF Page: 6 of 6
ANSiStim/ AuriStim/ P-STIM

12.0 VALIDATION REPORT:

A detailed report of the Sealing Validation shall be reviewed and approved by

DyAnsys India Private Limited.

13.0 PERSONNEL:

The personnel required to conduct the validation trials will be sufficiently trained in the
sealing process and operation of associated process. And the same shall be documented.

14.0 REFERENCE:

i) ISO 11607-1:2006(R)/2010 – Packaging for Terminally sterilized medical

devices- Part1:Requirements for materials sterile barrier systems and packaging
systems.

ii) ASTM F1929:2012 – Standard Test Method for Detecting Seal leaks in
Porous Medical packaging by Dye Penetration

iii) SOP for Detecting Seal Leakage in Medical Packaging by Dye penetration –
For Needle pack and Product pack. SOP No: SOP/QA/SINP/B & SOP/QA/SIPP/B

DIPL Confidential