You Were Already Informed That An Expansion Investment Has Further Increased Seeurity Of Our Hptnbspfuturenbspthe Time Is Now Ripe To Start Running Our New Hpt Cleanroom Ii Sinee Squot July 2010 Our Machinesnbspare Being Installed In This Locationnbspadditionally To The Expansion Of Our Cleanroom Produetion Investment Has Been Made Into A Newnbspinjection Blow Moulding Maehine Whieh Will Also Be Put Into Operation There In The Next Eouple Ofnbspweeksnbspin Order To Ensure Compliance To Both Pharmaceutical And Specific Customer Requirements Extensivenbspqualification Of Our New Cleanroom Machines And Production Tools Is Carried Outour Validationnbspmaster Plan And Realisation Of Aetions For Sopz30 Change Control Are The Basis Of This Extendednbspqualificationnbsplittle By Little All Production Lines Will Be Installed And Aeeordingly Qualified On Every Line Anbspvalidation Lot Will Be Made Prior To Offieial Produetion Start The Production Ability Of Our Lines To Anynbspbatch Production Will Be Verified With The Help Of Systematie Tests It Goes Without Saying That In Thenbsprunup Of All Activities The Complete Proeess Including Transfer Of Produetion Maehines And Tools Wasnbspplanned And A Risk Analysis Was Madeour Relocation Only Applies For Production Processes Like Injection Moulding Injeetion Blow Mouldingnbspand Injection Stretch Blow Moulding Our Extrusion Blow Moulding Equipment Will Remain In Thenbspexisting Cleanroom I Environmental Conditions Of New Cleanroom Hpt Ii Exactly Conform To Theexisting Cleanroom Production According To Gmp Class C Iso Class 8 In Operation Qualification Willnbspfollow Again Din En Iso 146441completion Of All Installation And Qualification Is Planned For End Of August In Order To Give You Thenbspopportunity Of Evaluating The Proper Realisation Of These Activities You Will Afterwards Be Able To Seenbspall Corresponding Documentation Within The Frame Of An Audit In Our Housenbspfurthermore We Would Like To Inform That All Measures Put Into Practice In Our Certified Company Arenbspaccording To Is0153782006 And Will Also Be Adopted In Our New Cleanroom Productionnbsp
