盘式干燥器,瓶子干燥机 英文使用说明、操作手册英文范本.doc

USER REQUIREMENT SPECIFICATION FOR Bottle Dryer ARTICLE 1: APPROVAL Raised By: Name Designation Signature Date Reviewed By: Reviewed By: Approved By: Revision History Sl No Revision on Date History 1 01 03.07.2013 New Article 2: Introduction This URS cover the design, manufacturer, inspection, testing and putting into the operation of Tray Dryers, together with supporting document of the equipment to be used in a ORAL LIQUID manufacturing department. This design must meet all cGMP guidelines and legislation. 2.1 Purpose Purpose of specifies the user requirement for a Bottle Dryer. 2.2 Scope This user requirement specification will be recognized as an integral part of the procurement agreement with the selected equipment vendor. The equipment supplier or vendor will be abide by the information and conditions set forth by this document as well as the standard purchasing term and conditions. 2.3 General Description The Bottle Dryer will be operated within the Bottle Dryer room of the new building 2nd floor under Clean Class - D. ARTICLE 3: OVERVIEW Bottle dryer utilize the principle of passing the hot air at a high velocity through the chamber of trays that contains material (Bottles) to be dried. The blower situated on the exhaust side of the dryer operates on negative pressure principle, which create the induced draught and sucks in the fresh air in to the dryer. 3.1 Use The Bottle Dryer will be used for drying of bottle to remove its water moisture content. Capacity Minimum 5,000 (Five Thousand) bottles of 100 ml /Load : 01 No. 3.3 Range of bottle 20 ml, 35 ml, 70 ml 200 ml. ARTICLE 4: Machine SPECIFICATION 4.1 Operation The machine should have following features in its respective parts – 4.1.1 Inlet Air Inlet air should be passed through 3-stage filtration. As- Pre filter (EU-4), Intermediate filter (EU- 8 / EU-9), Final HEPA filter (EU-13) of