OBJECTIVE of DQ of Disintegration Test Apparatus
To determine that the DQ of Disintegration Test Apparatus perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that Design consistently meets per-determined specifications under normal condition, and where appropriate the worst case situations.
TABLE OF CONTENT
| Description |
| Objective |
| Table of contents |
| Scope |
| Pre-Approval of Documents |
| Responsibility (client and manufacturer) |
| Scope of supply |
| Brief process description |
| Technical specifications |
| Safety features and alarms |
| Technical specifications |
| Post approval of Documents |
| List of Abbreviations |
SCOPE
The scope of this qualification document is to perform the Design qualification to verify the installed components as described in DQ.
PRE APPROVAL OF DOCUMENTS
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer Engineering |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Production |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
RESPONSIBILITY:
Customer:
To provide the Scope of supply.
To give final approval to drawing and technical data sheet.
Manufacturer:
To design, engineer and provide complete technical details of the Equipment.
To confirm safe delivery of the equipment to the user site.
To ensure that no un-authorized and/or unrecorded design modifications shall take place. If at any point of time, any change is desired by mutually agreed design, change control procedure shall be followed and documented.
SCOPE OF SUPPLY:
Design of the machine shall meet the Scope of Supply finalized with the Customer.
To define the customer’s & the manufacturer’s responsibilities.
To provide the brief process description of Disintegration Test Apparatus.
To provide the apparatus description.
To provide the technical Specifications of the apparatus.
To provide the information on bought out components.
BRIEF PROCESS DESCRIPTION for DQ of Disintegration Test Apparatus:
Disintegration Test Apparatus is a solid state instrument designed for the accurate estimation of disintegration time of tablets as per IP/USP standards. The instrument is designed to test two batches of six tablets, simultaneously. The instrument has two basket assemblies with independent timers and motors. The timers and temperature are displayed on 5 digits and 3 digit seven segments red LED displays respectively. Each timer can be set and used individually. The baskets are automatically positioned at the top when the test is over.
TECHNICAL SPECIFICATION for DQ of Disintegration Test Apparatus:
| Utility/ Parameter | Specification |
| Electrical Utility | |
| Dimension | |
| Enclosure Protection grade | |
| Sealing Diameter | |
| Height of the Bottle |
SAFETY FEATURE & ALARM
| Safety feature | Function | Identified by/Date |
| Electrical Insulation | Safety | |
| Earthling | To avoid the shock |
TECHNICAL SPECIFICATION for DQ of Disintegration Test Apparatus
A) Equipment structure:
| Sr.No | Description | Specified | Method of verification | Actual | Checked by |
| 1 | Make/Model | ||||
| 2 | Specification |
- Instruments Requiring Calibration
| Sr. No. | Instrument | Location | Model no. | SR. NO. | Yes/No |
| 1 | Volt Meter | OPERATING PANEL | |||
| 2 | Ampere Meter | OPERATING PANEL |
POST APPROVAL OF DOCUMENTS
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer Engineering |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Production |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
LIST OF ABBREVIATIONS
| IQ | Installation Qualification |
| DQ | Design Qualification |
| DT | Disintegration Test |