PharmaceuticalFacilities NewConceptinFacilityDesign

SanjitSinghLamba
ManagingDirector

Eisai Knowledge Centre, Vizag, India

INDUSTRYCOMPARISON

PHARMACEUTICALMANUFACTURINGISATA CROSSROADS
State of high variability Q lit by Quality b Inspection I ti Low OEE , BRFT, OTIF High cycle times Batch manufacturing High Waste High Inventory Less automated 90 % Pharma still paper based New product pipeline drying Less blockbusters Capacity utilization 30-40 %

DESIGNERNEEDSTOKNOW
Regulatory agencies that will have jurisdiction over operation Preparing URD , process and operational flow diagrams How to design a facility conceptual design Corporate philosophies Operating philosophies Knowledge of manufacturing process flows Material, ,p personnel and equipment q p flow p patterns Commissioning, qualification and validation approach Risk management

HUMANERRORFACTOR
Can you really design a human error free facility? Can we make procedures full proof for the peaks and valley of employee intellect ? Majority of lost batches was human error factor.

RISKASSESSMENTWORKSHOPS
What can go wrong? How can it go wrong? What is the potential harm? What can be done about it ? What problems have we experienced in the past? How did we manage it when it happened? How can we stop it from happening again? Wh t losses What l h have our competitors tit experienced? i d?

DOCUMENTTHERISKS
Risk ID and Text Description Affected Outcome Probability and Severity Ratings Level of Manageability Risk Owner Mitigation g Actions(s) ( ) and Owner Contingency Plan(s) and Owner

QUANTIFYIMPACT
CAPEX cost Project Schedule Construction Safety Facility Operability Environmental Company p y Reputation p

RISKASSESSMENTASPERICHQ9
Risk priority Number

Reference

Risk

Occurrence O

Severity S

Detection D

OxSxD
11 1.1 1.2 1.3 1.4 2.1 2.2 2.3 2.4 Receipt of Wrong material Receipt of damaged packs or containers Receipt of Hazardous material Receipt of container without Label Wrong material sampled. Sampling from damaged packs or containers Contamination of materials during sampling Sampling from Hazardous material 1 2 1 1 1 2 1 1 5 4 1 5 5 4 5 1 1 1 1 1 1 1 1 1 5 X1 8 X3 1 X1 5 X1 5 X1 8 X3 5 X1 1 X1

RISKEVALUATION
Risk Severity+Probability Vs Detection
5.Frequent 5 10 15 20 25

4.Probable

12

16

20

3.Occasional

12

15

2 R 2. Remote t

10

1.Improbable

RATING

1 None

2 Negligible

3 Marginal

4 Critical

5 Catastrophic

RISKMATRIX

Severity Mediu um High h Low w RiskClass ONE

High Pro obability y Medium Low

RiskClass TWO RiskClass THREE

DESIGNCONCEPTS
How to Avoid mix ups Take measures to avoid contamination Provide suitable materials flow around the facility Provide adequate space for operations Design to allow for easy cleaning Adequate q labelling g( (at p point of operation) p )

PREFERREDLAYOUT
Segregate raw materials and final products Segregate different production suites involving different classes of products Closed operations where possible Ensure an orderly flow direction Provide distinct staging areas if required between process steps Provide cleanable production suites and equipment Provide suitable environments for controlled areas where products and their active material are stored and processed

USATELLITEPROCESSASSURANCEHUB (USPAH) ( )
Adopt an overall unidirectional materials flow through the plant starting with raw materials in and final product out with two (relatively) small warehouses Maximize adjacency of materials storage with production suites Adopt a central spine in the building in both the support areas and process area around which materials flowed and the process functional rooms are located Maximize technical space p adjacency j y to p production rooms Provide IBC handling and discharge level above the process and filling rooms

USATELLITEPROCESSASSURANCEHUB (USPAH) ( )
Close adjacency of the QC/QA laboratory to all operations Minimize under utilized technical plant space and clean corridors Provide a visitor viewing gallery through the plant which maximizes visibility of the process areas without entering them Analysis of final product only with no interstage QA hold points, thus minimizing staging area requirements

SATELLITEPROCESSASSURANCEHUB SPAH
Segregated raw material and final product warehouses Clear and separate raw materials and final product flow paths through the plant Good access control of process personnel to production areas Availability of the technical space behind every production room, room allowing easy use of `through the wall technology to minimize congestion in the rooms Convenient location for a centralized information room to facilitate the implementation of the FDA initiative Through the wall technology is available for each production room, allowing less g process rooms easier to clean for multi p p product facilities congested

CLOSEDTRANSFERS

17

VACUUMLOADINGCLOSEDLOOP

18

Design concepts

IBC

RMG

Tablet Presses FBD

Bl d Blender

Tablet Coater

Packaging Line

DESIGNCONCEPT II

IBC

Potent Product Dissolution Vessel

Tablet Presses

FBD Blender Tablet Coater

Packaging Line

CONCEPT III

Single Bowl Roto Granulator Tablet Presses

Vacuum Conveying

Blender

Tablet Coater

Packaging Line

FACILITYDESIGN
Flexible and Agile Facilities
Modular designs Disposable /Dedicated Equipment Innovation Continuous improvement Expandable Risk based Use of PAT Virtual IT networks

MANUFACTURINGEXCELLENCE
Better Quality Higher Throughput Greater Availability More Productive Operations and Maintenance Streamlined Safety, Safety Health & Environmental Compliance Lower Utility y Costs Less Waste

CREATINGOPERATIONALEXCELLENCE

Excellence in Operations
Goal1 Reduced manufacturing costs Metric1 Revenuevs. manufacturing costs Goal2 Improved inventory situation i i Metric2 Coveragedaysof inventory Goal3 Betteruseof assets Goal4 Topqualityand efficiencyinall processes Metric4 Rightfirsttime Goal5 Servicelevel excellence

Metric3 Revenuevs. manufacturing fixedassets

Metric5 Ontimeinfull delivery

24

VISIONFORFUTURE
Product quality and performance achieved and assured by design of effective and efficient manufacturing processesFlexible Continuous real time assurance of q quality y PAT Regulatory policies and procedures tailored to recognize the level of scientific knowledge supporting product applications, process validation and process capability. Riskbased manufacturing and quality systems Continuous processing

25

26

BIRDEYEVIEW

STATEOFARTFACILITIES

28