JETTBarrierIsolatorURS.docx

1、JETTBarrierIsolatorURSUser Requirements Templatefor a BARRIER ISOLATOR AND HVAC SYSTEMREVISION HISTORYRev.DateApprovalRevision SummaryA111/06/01T. PetroDraftA201/15/02T. PetroIncorporated content and changes from review by JETT break-out group on 11/15/01.B13/1/02M CaseyValidation review C111/20/02M

2、 RiveraFormat ReviewC211/26/02T. PetroFinal review of content and format by author011/26/02T. PetroApproved for Initial ReleaseTable of Contents1.0 Introduction 52.0 Overview 53.0 Operational Requirements 63.1 Capacity 63.2 Process Requirements 63.3 Process Control 63.4 Functions 73.5 Data and Secur

3、ity 93.6 Environment 114.0 Constraints 144.1 Milestones and Timelines 144.2 Equipment Constraints 154.3 Compatibility and Support 154.4 Availability 174.5 Procedural Constraints 174.6 Maintenance 195.0 Life-Cycle 195.1 Development 195.2 Testing 195.3 Delivery 205.4 Support 216.0 Glossary 227.0 Refer

4、ences 238.0 Approval 24Project No.:Insert the unique project number associated with this particular URS.Document No.:Insert the Document Identification Number and Revision.Document Description:Insert description of document, e.g. PURE STEAM GENERATOR, JETT Example User Requirements Specification.Int

5、roductionNote: Insert your own description and introduction. You may wish to include your own requirements and specifics to allow the inexperienced reader, contractors, and suppliers adequate explanation to understand the scope of the equipment.Describe who produced the document, under what authorit

6、y, and for what purpose.Describe the contractual status of the document. Include or reference as an attachment the “legal” paragraph that communicates purchasing terms and conditions in this section.Describe the relationship of this document to other documents. This is important for equipment that i

7、s part of an integrated process or line and will help the Supplier to understand and ask questions that may otherwise be overlooked.Refer to the Equipment Validation Plan that outlines the Suppliers responsibilities is attached.Remove any options that are not applicable for this project, if other us

8、es will apply list each separately.This is to be utilized as a guide for the user to answer the majority of questions involved in specifying the “what” for the equipment. Addendums may be used to round out the requirements.OverviewThe Barrier Isolator and HVAC System provides a mechanical separation

9、 between the controlled room environment, and the interior environment in which the pharmaceutical product is processed. The barrier isolator is manufactured in such a manner that the materials are resistant to corrosion, do not allow pooling of the cleaning materials, and allow access to the interi

10、or as required by the equipment and products. The environment inside the barrier isolator is controlled in a manner to allow the pharmaceutical product to be processed in accordance with the purpose and product requirements.USEThe equipment shall be used primarily for: Continuous Production Batch Pr

11、oduction OtherEQUIPMENT CLASSIFICATIONFor example:For providing an aseptic environment for: Liquid filling of vials with stoppers Powder filling of vials with stoppers Liquid filling of ampoules with flame-off Liquid filling of cartridges with plugs Liquid filling of syringes Other (define)Insert yo

12、ur Equipment Classifications here as required using the above example as a guide.CLEANING REQUIREMENTS Wipedown Manual Washdown Clean-In-Place (CIP) Special Requirements: Peracetic Acid Ethylene Oxide Chlorine Dioxide Vaporized Hydrogen Peroxide OthersLANGUAGE REQUIREMENTS English Other (Specify): _

13、 Bilingual? Yes / NoOperational RequirementsPERFORMANCE REQUIREMENTS CapacityAdd capacities and details concerning equipment capacity here. Identify the type and dimensions of the equipment that will fit inside of the barrier.FUNCTIONSThe Barrier Isolator and HVAC System is divided into two main por

14、tions: The barrier isolator, and the HVAC system.Barrier Isolator Operation The barrier isolator is an enclosure that provides isolation between the operator/outside environment and the interior of the barrier where the pharmaceutical processing is done. The barrier isolator provides the following f

15、unctions: Isolation between the operator and the process Safety Barrier to separate the operator from equipment hazards A non-corrosive, drainable, and easily cleaned enclosure. Doors to provide access to the equipment during cleaning and changeover Gloveports to allow access to machinery and produc

16、t during production Transfer ports to introduce commodities and equipment to the environment Infeed opening to introduce commodities to the system. Exit opening to allow finished commodities to exit the system.Barrier Isolator Design The barrier isolator design will meet current GMP for aseptic prod

17、uct manufacture, along with wash down and sanitization requirements.All interior corners will have a minimum of _0.5”_ radius.Drain pans will have a minimum of _0.5”_ slope per 12” of run.Horizontal surfaces will be minimized to resist pooling. Pooling of more than _5ml_ of liquid is not allowed. Po

18、oled liquid must not be more than _2mm_ deepDrain pans shall terminate in tank bottom drain valves with materials and finish equivalent to the rest of the barrier isolator interior.Air distribution from the plenum will use _dual perforated plates_.The air distribution system will be removable for cl

19、eaning.Safety of the operator from the machinery or processes within the barrier isolator must be ensured.All doors will have dual-redundant safety switches that will immediately stop all machinery or processes when the door is opened.Gloveports will be guarded with light curtains to immediately sto

20、p machinery.All moving machinery external to the barrier isolator will be fully guarded and alarmed.All high temperature components external to the barrier isolator will be fully guarded and alarmed.Materials and Finish of the Barrier Isolator will meet current GMPs. 1. Wall thickness of the barrier

21、 isolator will be a minimum of _7gauge_ Stainless Steel2. Interior surfaces of the barrier isolator will be manufactured from _316L_ Stainless Steel.3. Exterior surfaces of the barrier isolator and ductwork will be manufactured from _304 or316L_ Stainless Steel.4. Interior finish of the barrier isol

22、ator will be of _40_ micro-inch Ra finish maximum.5. Exterior finish of the barrier isolator will be of _120_ micro-inch Ra finish maximum.6. All interior surfaces will be electro-polished redundant? How else do you get #4 and #5?.7. All welds will be ground and polished to the above finish requirem

23、ents.8. Air plenums must meet the same materials and finish requirements as the barrier isolator.9. The completed interior of the barrier isolator will be passivated prior to shipment to the site.10. Components attached to the exterior of the barrier isolator must meet current GMPs and be finished t

24、o resist corrosion.Doors and Windows in the barrier isolator allow visibility and access to the interior.1. The window material is manufactured from _tempered safety glass or polycarbonate_.2. The window sealing material is extruded from _silicone rubber_.3. Window seals must be designed to prevent

25、pooling.4. Doors must hinge open to allow access to the interior.5. Doors must be removable without tools.Mousehole Opening(s) are provided at the exit point to allow the exit of good vials and of reject vials.1. Mousehole covers are manufactured to the same requirements as the barrier Isolator.2. M

26、ousehole cover presence is to be sensed and alarmed.Gloveports are provided in the barrier isolator to allow operator access to the interior without compromising sterility.1. Gloves must be replaceable.2. Gloves must be sanitized without absorbing sterilant.3. Gloves will be made from _fabric reinfo

27、rced PVC_.4. Gloves will be located to access common intervention points.5. Gloves will be positioned to allow access by operators within the normal range of physical sizes.Transfer Ports will be provided to allow component and product entry into the interior of the barrier isolator without compromi

28、sing sterility.1. Transfer ports will be located at the following locations, and are of the following sizes:Location #1: _upstream of filler_ _350mm_Location #2: _at stopper entry_ _270mm_Location #3: _at outfeed_ _270mm_Location #4: _N/A_ _2. Transfer port manufacture is _3. Transfer port sanitizat

29、ion process is _Commodity/Product Infeed to the interior of the barrier isolator will be provided in the design.1. Vials enter the barrier isolator from a _depyrogenation tunnel_.2. Product enters the barrier isolator through a _bulkhead fitting_.3. Stoppers enter the barrier isolator through _trans

30、fer port #2_.4. Miscellaneous Devices such as:_tools, SMA stands, hangers, platforms, instrumentation, test ports, etc._Product Exit from the interior of the barrier isolator will be provided in the design.5. Vial path #1 transfers vials to a _flat belt conveyor_.6. Vial path #2 transfers vials to a

31、 _22” transfer disk_.7. Drains in the bottom of the barrier isolator are provided at _7_ points to allow for liquids to be removed during changeover and sanitization.8. Drains must be closed during production.HVAC System Operation The HVAC system controls the environment inside the isolator, and provides the following functions: Pressure differential between the interior and exterior of the isolator Temperature control of the i