JETTBlende URS.docx

1、JETTBlende URSUser Requirements Templatefor a BLENDERfor Pharmaceutical productsNOTES for use of the User Requirements Template:Upon completion of the template, delete this page prior to updating the Table of Contents and printing.1. Many areas of this template have selections or tables that have be

2、en prepared for guidance and ease of template completion. Text in italics is intended to be used as notes to the User and should be deleted prior to printing. Any options and/or examples that are not applicable to the specific document being created should be deleted as well.2. To update the final T

3、able of Contents, place the cursor inside the shaded area, press the Right mouse key, and select Update Field.3. Where possible, the User should identify the source (e.g. studies, standards, etc.) for the acceptable ranges of variables or other critical requirements that have been derived.REVISION H

4、ISTORYRev.DateApprovalRevision Summary0July 27, 2003Vince Miller (JETT)Approved for initial, formal release.Table of Contents1.0 Introduction 52.0 Overview 52.1 Use: 52.2 Capacity: 53.0 Operational Requirements 63.1 Capacity 63.2 Process Requirements 63.3 Process Control 73.4 Functions 73.5 Data and

5、 Security 133.6 Environment 174.0 Constraints 204.1 Milestones and Timelines 204.2 Equipment Constraints 214.3 Compatibility and Support 214.4 Availability 234.5 Procedural Constraints 234.6 Maintenance 255.0 Life-Cycle 255.1 Development 255.2 Testing 255.3 Delivery 265.4 Support 276.0 Glossary 287.

6、0 References 298.0 Approval 30Project 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. BLENDER User Requirements Template, JETT Example User Requireme

7、nts Specification.1.0 IntroductionThis document was generated under the authority of the _ Company for the purpose of specifying the user requirements for an automated blending system. The system shall be used to perform a diffusion blending step in which an active pharmaceutical ingredient is combi

8、ned with inert dry ingredients to form a uniform mixture. 1.1 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 abide by the information and conditions set forth by this do

9、cument as well as the standard purchasing term and conditions of the _ Company. 1.2 The blending system will be operated independently of other equipment and systems and will be located in a designated operating area.1.3 An equipment validation plan has been developed to outline the planned tasks an

10、d expectations for validation of the blending system. This plan has been included as Attachment _. The equipment supplier or vendor has specific responsibilities as outlined by the Validation Plan and this document.2.0 Overview2.1 Use:The Blender shall be used to combine a dry bulk active pharmaceut

11、ical ingredient (medium active) with two inert dry compounds to produce a uniform blend to meet formulation requirements. 2.2 Capacity:The blender shall be capable of handling 500 cu. Ft. of dry product per batch. 3.0 Operational RequirementsThere are many types of blenders, each providing certain f

12、eatures that might be applicable to a given process or product need. This section should describe the specific technology which will be utilized for a specific process requirement. The major blender types are:1. Ribbon2. V-Cone or V-Shell3. Y-Cone4. Double Cone5. Fossberg, high speed blender6. Verti

13、cal cone screw blender / Conical orbital screw mixer7. Ribbon blender8. Zig-Zag Blender9. IBC BlenderEach type has unique features and capabilities to fit a particular process need. This section should provide an overview of the unique features required for the specific process application. The user

14、 should describe the basic operating principles required by the product formulation specifications, such as diffusion blending, convection mixing, or pneumatic mixing.3.1 CapacityDescribe the batch size and throughput requirements. (Batches per day, pounds per hour). It is important to clarify both

15、the minimum and maximum batch sizes. Some blenders will have a minimum percent full load requirement for an effective blending action. Maximum volume/capacity required. Minimum volume/capacity required. Range of products ( i.e. density, moisture content, viscosity, etc.) Commodities to be used (i.e.

16、 types of containers, or methods, used to charge and discharge materials to be blended.) Processed Materials to be used or involved Production rates3.2 Process Requirements Quality of products and concentrations Product limitations (i.e. temperature, humidity, pH, etc.) Blending time Blending speed3

17、.3 Process ControlNote: At a minimum, list the critical process parameters. Consider documenting how each of the parameter requirements was determined. Measurement Range Setpoint Range Parameter Control Tolerance3.4 Functions3.4.1 OperationThe operational requirements for a blender can include one o

18、r more of the following: Even distribution of components Wet granulation Agglomeration Drying Temperature control Variable speed drive Soft start High speed chopper Spray nozzles Describe any constraints required by the process application, such as maximum tip speed and/or RPM limitations. Describe

19、any portability requirements such as casters, utility connections, etc. Describe drive location or acclimation requirements. Describe any platform height requirements. Describe the number of recipes and recipe parameters that will be required. Describe the method of defining recipe parameters. If th

20、e machine will be monitored and/or controlled by a SCADA or MES system, describe the data interface requirements. See section 3.2.3.Enter your specific operational requirements here. Cycles expected the system will operate at are Recipes the system will contain are Operator interaction with the syst

21、em will includeThe following is an example:The system shall operate with a minimum of operator involvement. Operation shall be safe from an operator and environmental standpoint.The system shall be operated locally at the equipment itself.Control system requirements: Manual only Manual/automaticOper

22、ational parameters can be defined in narrative or in a table, as illustrated below:ParameterIndicated on Local HMIMonitored remotelyOperator adjustableDetermined by recipeData stored/trendedRotation speed# of rotationsBlend timeProduct temperatureVapor outlet temperatureShell in/out temperatureDrive

23、 torqueVacuum levelIntensifier speedIntensifier powerIntensifier flow rateAgglomeration timeBlender load weightFinal Blend Yield 3.4.1.1 Loading Describe how the blender will be loaded. Specify aseptic or non-aseptic3.4.1.2 UnloadingDescribe how the blender will be unloaded. Specify aseptic or non-a

24、septic3.4.1.3 CleaningDescribe the cleaning requirements for the unit. Will an automated clean-in-place system be used? Will the unit be used for more than one product?3.4.1.4 SanitizationDescribe any sanitization requirements for the unit.3.4.1.5 Other requirements. Alpha-Beta valve for sanitary un

25、loading Johnson joint for process connections to rotating parts enclosed drive system remote drive system list any sterility or containment requirements ASME Vacuum/pressure rating Describe operator access points and the method of operator access, i.e. platform height and alignment. Dust collection

26、systems Safety features such as:o E-Stopo Photo eyes or light curtain to disable drive operation when operator is present.o Door interlockso No auto-restart after failureo Fail safe design on valve actuators. Consider double-acting (fail in last position) vs. spring return (fail closed) actuators wh

27、ere hazard to operator exists.o Lockout features on all energy sourceso Room pressurization interlock3.4.2 Power failure/RecoveryPower Failure: On power failure, the system shall fail into a “safe state.” On power restoration, the system shall not restart without operator or communication-link input

28、. Insert your specific power failure/recovery scheme here.For example:In the event of a power failure, the system shall protect in the following priority: Personnel Equipment ProductA “safe state” shall be defined as: All motion stopped on the machine Reset required before machine can be restarted N

29、o damage to machine will occur as a result of going to the safe state. Valves and actuating devices go to safe state (define). No product loss. Batch can be restarted without loss of batch ID or batch status data. List each sequence or process step and the desired fail state for each. List any autom

30、ated remedial action to be taken in the event of sensor or instrument failure.Recovery Methods: Insert your specific recovery scheme here.For example: Manually re-start based on operator inputs (Operator initiates power recovery sequence). Re-start based on last state before loss of power. (System r

31、uns through power recovery sequence when operator start signal is given) All equipment shall be designed to retain the PLC program in case of power loss, and be able to recover with minimal operator actions. If there is an automatic batch reporting system, the information shall be retained in the event of a power failure (A UPS is requir