Kreation Handicraft

Design Qualification
Equipment
Page Number 1 of 5
Name Pouch filling and Sealing machine
Protocol Revision
KH/DQ/001 00
Number Number
Equipment ID IA

Prepared by
Name/ Designation Signature Date

Vikal Sharma/Manager Quality Assurance

Remark:

Approved by (Validation Team)

Name Department Signature Date
 Kreation Handicraft
Design Qualification
Equipment
Page Number 2 of 5
Name Pouch filling and Sealing machine
Protocol Revision
KH/DQ/001 00
Number Number
Equipment ID IA

Table of Contents

SERIAL TITLE
NUMBER

1.0 Objective

2.0 Scope

3.0 Responsibility

4.0 Equipment Description

5.0 Technical Specification / Details

6.0 Deviations and OOS if any

7.0 Reference

8.0 Attachments

9.0 Summary

10.0. Conclusion
 Kreation Handicraft
Design Qualification
Equipment
Page Number 3 of 5
Name Pouch filling and Sealing machine
Protocol Revision
KH/DQ/001 00
Number Number
Equipment ID IA

1.0 Objective:

The Objective of this protocol is to define the criteria for Design Qualification of Pouch filling and
sealing Machine. This protocol ensures the documented evidence that the Pouch Filling and sealing
Machine is designed as per required specification/Functional Specification and equipment meets the
current Good manufacturing practice (cGMP) requirements.
2.0 Scope
This protocol will define the test procedures, documentation references and acceptance criteria,
which will establish Pouch Filling and sealing machine is designed according to Kreation
Ointment/cream/ Gel Products, Dehradun requirements.
3.0 Responsibility
Preparation of this protocol-Maintenance department/Production/Quality Assurance
Review & execution of this protocol-QA, Engineering, Safety & Technical
Assembling all DQ data-Maintenance department/Production/Quality Assurance
Approval-Quality Assurance
Supplier-Nidan Packaging

4.0 Equipment Description:

Equipment Make / Model Equipment I.D. Working Capacity
Name Number
Pouch filling & Nidan Packaging /
1A
Sealing Modle-NP-800L 60-65 stroke/minutes
Machine

The Equipment is named as Pouch Filling and sealing machine- NP800 L which is used to pack liquid or
semi liquid. The system is consisting of a hopper for filling of liquid or semi liquid and it is made up SS 316.It is
equipped with Top lid. The speed of the machine is up to approximately 65 strokes per minutes.
 Kreation Handicraft
Design Qualification
Equipment
Page Number 4 of 5
Name Pouch filling and Sealing machine
Protocol Revision
KH/DQ/001 00
Number Number
Equipment ID IA

5.0 Technical Specification / Details

Serial
Number Description (NP 800L) (Yes/No or Remarks)
1 Pouch filling & sealing machine NP 800 L
2 Gross Capacity of hopper – Approximately 70
kg
3 Hopper Made up food grade SS 316
4 Hopper Top Lid made up food grade SS316
5 Horizontal heater & Vertical heater
6 Number of tracks
7 Main motor - 3 HP, AC, 3 Phase, 440 volts
induction motor
8 Power consumption - 10 KW
9 Dimensions (3.25 m (L) x 1.6 m (w) x 2.7 m (H)
10 Air required 12 CFM at 6 kg/ cm. square
11 Net Weight 2400 kg
12 Speed - Approximately - 65 strokes /minutes
6.0 Deviation & Out of Specification(s) if any:

______________________________________________________________________________________________

______________________________________________________________________________________________

7.0 References (if any):

______________________________________________________________________________________________

______________________________________________________________________________________________

8.0 Attachments:

Attachment Details
 Kreation Handicraft
Design Qualification
Equipment
Page Number 5 of 5
Name Pouch filling and Sealing machine
Protocol Revision
KH/DQ/001 00
Number Number
Equipment ID IA

9.0 Summary:

______________________________________________________________________________________________

______________________________________________________________________________________________

10.0 Conclusion:

The Pouch filling and sealing machine (IA) has been tested and verified for Design
Qualification as per the Protocol.

The equipment stands Qualified / Disqualified as per the observations made therein.

Hence it is concluded that equipment stands Qualified / Not qualified for Installation
Qualification.