Parenteral Filling Facility Automation Case Study. Shawn Hull, Avid Solutions JV Cotterell, Eisai Inc

Transcription

1 Parenteral Filling Facility Autmatin Case Study Shawn Hull, Avid Slutins JV Ctterell, Eisai Inc

2 System Overview Greenfield Parenteral Filling facility with tw filling lines (Cmmercial Line and Clinical Line), Micrbilgy Lab, Inspectin, Packaging, Waste Treatment, and Warehuse Strage 8 Prgrammable Autmatin Cntrllers (PAC) prvide direct cntrl f nn OEM equipment and batch/sequential cntrl. 15 Thin client Human Machine Interface (HMI) prvide visualizatin t the facility via redundant terminal servers 8 Mbile devices (ruggedized tablets and handheld cmputers) prvide wireless access fr visualizatin and data entry Data histrian prvides histrical data cllectin

3 System Overview (cnt.) Mnitr and cntrl f all HVAC (Direct and Indirect Impact) 7 AHUs Mnitr and cntrl f clean utilities strage and distributin WFI, Clean Steam, etc Mnitr and interact with 28 pieces f skid equipment Varius PLC/HMI vendrs Prvides verall batch executin and cntrl fr majr peratins Serves as the traffic cp fr all data transfer Aggregates data fr prductin reprts

4 System Gals Develp a layered but unified system fr the entire facility Displays, actins, etc are cnsistent fr all parts f the system Access t key functins, displays, data, reprts fr all peratin and equipment frm ne system One stp shp fr the facility Prvide verall crdinatin fr all batch activities n the line Prvide a central repsitry fr recipe data and data management Prvide a central repsitry fr batch and prcess data System needs t prduce electrnic batch reprts Act as interface t ERP system in rder t prvide MES type functins

5 Cnsistency Thrughut A system must appear cnsistent t users at all layers in rder t serve as unified system The Easy Things Graphic clr schemes, brders, symbls Navigatin f system, printing activities Starting equipment, entering set pints, changing mdes The Nt S Easy Things Cmmn lgin fr all equipment, mst imprtantly OEM skids Cnsistent methd fr initiating batch and unit peratins whether it is an autclave, islatr, r CIP prcess. Batch reprts fr all prcess and equipment appear similar in the type f data prvided and the methd f presentatin Interface t a partswasher lks the same as the interface filler, just different data. Data transfer methds are transparent t user, it just wrks!

6 ERP Integratin 1. Prcess Orders, Bill f Materials, and Inventry are transmitted frm SAP 2. Decupled interactin via XML file drps ver FTP n 15 minute cycle. Current schedule is less than 5 unique rders per week s real time data exchange is f little value. 3. Orders are available fr selectin by peratrs upn receipt.

7 ERP Integratin 1. Order status is cmmunicated as phases (cmpunding, filling, packaging) advance thrugh different states (started, held, abrted, cmpleted) 2. At the cmpletin f each phase cnsumptin data is transmitted with direct linkage t received inventry, supprted by Asset Tracking system. 3. Prductin Data is transmitted at rder cmpletin

8 Real Time Asset Tracking If a material is received frm Inventry (SAP) r Cleanliness/ Sterility is tracked the item receives a unique barcde fr tracking. Operatrs Receive cnsumable materials frm SAP Inventry, generating a new barcde. All materials passing thrugh a partswasher r autclave receive a barcde. Barcdes are marked clean, sterile, and dirty based n equipment activity. Operatrs scan barcdes as they mve the materials in the suite. Barcdes are assciated with cycles and reprted in electrnic batch reprts.

9 Batch Cntrl Hw d yu prvide batch cntrl f a prcess when: The equipment invlved is standalne and nt necessarily designed with a higher level system in mind. Yu d nt have direct cntrl ver the equipment invlved. The equipment needs data that it des nt wn. ANSWER: GET INVOLVED EARLY WITH THE VENDOR AND GET IN THE MIDDLE OF EVERYTHING

10 Batch Cntrl (cnt.) Every prductin peratin is gverned by a predefined prcedure in the facility system regardless f what equipment prvides final cntrl. CIP, VHP, vial washing, filling, cmpunding, manual cleaning, autclaves, etc Acts as the gatekeeper and enfrcer fr all prductin peratins All prductin prcedures must be initiated frm the facility system All prerequisites must be met befre prceeding in a prcedure Rm cnditins, utility status, equipment status (clean/dirty), envirnmental mnitring. These are things that the gatekeeper knws but the equipment des nt. The system must have the ability t enfrce and issue bth hard and sft stps t the equipment shuld smething g wrng.

11 Batch Cntrl (cnt.) System must act as the data traffic cp Any data needed by anther piece f equipment cmes thrugh the system, including interlcks and permissives Data quality, value, status is always knwn and can be cnveyed t the user Prcedure structuring is imprtant Everything is cnsidered an peratin r cycle t allw flexibility

12 Batch Cntrl (cnt.) Step 1 Track yur Cycles 1. Cmplete cntrl and visibility f GMP cycles Autclaves, Partswashers, Filter Integrity CIP, SIP, Decn Cmpunding Operatin High level Filling and Packaging Prcedures 2. Filling Line, Packaging Equipment Equipment requests release fr specific cycles Operatr driven frm equipment HMI Each release is assigned a unique Cycle ID Assciatins are made at the cycle generatin stage whenever feasible. (Cmpunding and Packaging)

13 Batch Cntrl (cnt.) Step 2 Assciate Cycles 1. Direct assciatin at cycle generatin 2. Equipment Cleanliness and Sterility (CIP, SIP, and Decn) Time and Event Based CIP SIP Equipment Use Cycle Decn 3. Cnsumable and Durable Gd Cleanliness and Sterility Barcde and Event Based Partswash Autclave Equipment Use Cycle 4. Sequence f Events 5. Assciate with SAP Prcess Order by peratr selectin at the start f the cycle.

14 Batch Cntrl (cnt.) Pulling It All Tgether SAP Prcess Order Cmpnent Preparatin Autclaves Partswashers Cmpunding Cmpunding Vessel CIP and SIP Hard Gd Assciatin t Cmpnent Prep Cycles Filling Equipment CIP and SIP Hard Gd Assciatin t Cmpnent Prep Cycles VHP (Sterility) Cycles fr Islatr Cl Zne Sterilizatin fr Depyrgenatin tunnel Packaging

15 Batch Cntrl (cnt.) Why use a batch prcedure t cntrl everything, even manual activities and peratins carried ut slely by underlying equipment? The bvius reasn prcedures enfrce wrkflw f bth manual and autmatic activities The nt s bvius reasn event and data cntext fr the batch reprt

16 Recipe Management Recipe and cycle parameter managed in a single lcatin - recipe database Prvides ease f management and tighter cntrl f validated parameters Nn-prductin recipes (maintenance, setup, cycle develpment) nt stred in the recipe database t prvide flexibility. Recipe data is either dwnladed t the equipment r verified prir t allwing a batch t start. Sme vendr equipment was set up t receive recipe parameters frm the facility system. Required early crdinatin with the skid vendr (need a place t send the data) Fr these systems, recipe data is dwnladed frm the recipe database directly t parameters n the equipment PLC. Data is verified after dwnlad cmpletes t check integrity f the transfer.

17 Recipe Data Management (cnt.) Sme vendr equipment was NOT set up t receive recipe parameters frm the facility system recipe database. Either the vendr refused t set their system up t receive recipe data r we were t late t get the requirement int the specificatin. Fr these systems, recipe parameters residing in the equipment PLC are cmpared/verified against the recipe parameters in the recipe database. Recipe parameters must match prir t issuing the permissive t start a cycle. Able t utilize ff the shelf capability f system fr recipe management and recipe transfer Allwed fr viewing and editing f recipe parameters by authrized users in a familiar frmat.

18 Recipe Data Management (cnt.) Benefits f cntrlling and cnslidating ALL recipe data Central lcatin fr management Cnsistent structure f data, regardless f destinatin Guarantee the right recipe data gets used every time Dynamic access t data fr batch reprting: cmparing data against limits, cmparing run times against targets, recipe versin, authr etc.

19 Data and Access Management Fllwed the idea that a single system shuld hld all imprtant data Data Histrian mnitred and lgged cntinuus data. HVAC fan speed, Rm DP, Autclave temperature, stability chamber temperature, etc. Data histrian lgged data frm ALL equipment, including OEM skids Alarms and Events mnitred and lgged alarm and event data. Prcess alarms, interlcks, verrides/bypasses, starts/stps, setpint changes, etc Alarms and events lgged frm ALL equipment, including OEM skids Material Tracking material tracking data stred in system database Lcatin, quantity, expiry, lt infrmatin, Equipment and Rm status status tracked and stred in system database Last CIP, current state, time left, rm status, etc

20 Data and Access Management Fllwed the idea f a single lgin fr all peratins, including OEM equipment Utilized Active Directry fr all lgins Users centrally managed OEM systems utilized ur lgin system, takes vendr buy-in up frnt f curse Users assigned access t areas and equipment based n training qualificatins Recrd f all users at all equipment at all time

21 Batch Reprting Majr Gals Electrnic batch reprts fr all autmated equipment (n mre strip charts) Prductin f cycle level reprts that culd be cmbined t create the final batch reprt. Cmmn layut fr all reprts Cmmn headers and fters fr all batch reprts Cmmn sectins fr similar types f reprts: Recipe parameters/targets Charts with dynamic limits (based n recipe) and data specific t time f batch Pertinent cycle data Exceptin reprting alarms, events, excursins

22 Batch Reprting (cnt.) Data frm varius surces Prcess Data Temperature, pressure, humidity Alarm and Event Data Bypass, verride, manual cntrl Recipe Data Cycle data User data Reprts are available fr all peratins Autclaves, parts washers, cmpunding, CIP/SIP, filling line, packaging line Reprts identified by cycle ID and batch ID as apprpriate

23 Batch Reprting (cnt.) Reprt presentatin Online, n-demand access as the prduct mves thrugh the prductin cycle Retrieve nline reprts by batch ID Reprts can be printed and attached t the manual batch recrd Reprt Strage and Distributin Available via web page Data stred electrnically fr reprts Reprts are saved t PDFs Reprts can be printed Reprts can ed t a distributin list