ZTLearning bio pharmaceutical focus ebook

ZTLearning eBook: Biopharmaceutical Focus

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ZTLearning Biopharmaceutical Focus www.ztlearning.com 1

About ZTLearning

ZTLearning is a learning solutions provider focused on operations in the Life Sciences industry. With over fourteen years of unrivaled experience in automation systems, pharmaceutical and biotechnology processes and the development and delivery of innovative and technically advanced training solutions and products, we support our Life Science customers to optimize, achieve and exceed their overall business objectives.

Our solutions and products add real value to the customer’s enterprise. We deliver business benefits through sharing and development of ideas that supply real and tangible results. By maintaining our customer focus, we provide superior support and advice throughout the life cycle of the solution.

ZTLearning are committed to being the long term partner to companies in the Bioscience industry who strive to:

Improve their corporate competitiveness by up-skilling their personnel Reduce wastage of raw materials by making more efficient use of

automation technologies Avoid breaches in product quality by reducing human error throughout

the production cycle Avoid partial or complete batch losses by having highly trained

Operations personnel who know how to best respond to out-of-normal events

With 14 offices across Europe, USA and Asia, we are ideally positioned to provide you with the appropriate level of training for your operation. Whether your focus is on mobilizing a workforce at plant start-up, reducing waste associated with existing classroom or paper-based training courses, introducing new technology or scaling to train for a global system deployment, our cloud-hosted eLearning and Blended learning approaches are tailored to suit the specific needs of your operation.

This eBook has been written to share our insights into learning and training approaches that bring the greatest value of profitability, competitiveness, and compliance to Bio-Pharmaceutical Operations.



CONTENTS

Introduction 3

Clean In Place (CIP) 4

Steam in Place (SIP) 6

Water For Injection (WFI) 7

Clean Steam 8

Clean Compressed Air (CCA) 9

Formulation 11

Heating, Ventilation, & Air Conditioning (HVAC) 12

Bioreactors 13

Bioprocess Filtration 16

Precipitation 17

Centrifugation 18

Waste Containment and Processing Systems 19

Controlled Temperature Environments 20



INTRODUCTION

Creating new biopharmaceutical products and vaccines is time consuming, high risk, and costly. After clinical trials and once approved by a regulatory body, there is then the challenge of manufacturing these products and vaccines in large scale production. To do this there is a need for the repeatable and precise control of automation technologies and applications. However in addition to selecting, designing, building and commissioning automated systems there is a requirement to train the Operations workforce to be competent in using them.

The focus of this eBook is both the automation system- and process-related training approaches that bring the greatest value – profitability, competitiveness, and compliance – to companies in the Bioscience industry. Leveraging our unique combination of knowledge in biotechnology processes, automation and eLearning and blended learning, each chapter in this eBook will:

Outline a typical automation application used for large scale bioprocessing

Describe key difficulties that arise requiring human intervention for it

Suggest related training approaches to reduce human error in causing these difficulties

This eBook is a summary of recently published blog posts >> http://info.ztlearning.com/blog/ . Add us to your favorites or subscribe to receive notification of new posts relating to learning solutions in Life Sciences operations.

Credit:

The book “Automation Applications in Bio-Pharmaceuticals”, ISA, 2008, has informed much of the content of this series and is highly recommended for those who wish to further research these topics.




https://www.youtube.com/watch?v=ajeIjx62bX0


CLEAN IN PLACE (CIP)

TYPICAL AUTOMATION APPLICATION

A Clean-In-Place (CIP) system is used to supply acidic and basic cleaning solutions, hi-purity water and/or lower purity water to piping and vessels both before and after use to remove chemical residues and particulates that would contaminate a product.

KEY DIFFICULTIES THAT ARISE REQUIRING HUMAN INTERVENTION

Transfer panel/Manifold connections are configured incorrectly

Liquid pooling has occurred

Clean status not set

CIP tank or skid unit cannot be acquired

Mechanical issue with a valve

Pressure test failure

Low flow during CIP burst cycle

Failure to reach conductivity due to failure during batching CIP

solution

High conductivity limit exceeded during final rinse

Line and tank pressures are not confirmed before either man

ways are opened or valves are manipulated etc.

RELATED TRAINING APPROACHES TO REDUCE HUMAN ERROR

GOWNING AND HANDLING TRAINING:

Since Potassium hydroxide (a strong base that is dangerous upon exposure) is often used during the Caustic cleaning cycle, safety training on the use of splash goggles, gloves, chemical resistant aprons, and vapor filter respirators is essential.

STANDARD OPERATING PROCEDURE (SOP) TRAINING:

Knowing how to review field connections for transfer panels etc. against SOP requirements is essential.

PHYSICAL EQUIPMENT AND PLANT LAYOUT TRAINING:

This includes how to recognize instruments and equipment by location, type, and state.



BATCH SOFTWARE TRAINING:

Introductory software training to access, navigate and interpret the batch software.

How to review the Batch control software resource acquisition for the CIP Tank is an important

skill.

How to review the Tank graphic and check the ownership of valves/equipment in use to

determine what/who else has acquired them to learn why they are not available are essential

troubleshooting skills also.

Advanced software training to carry out simulations of CIP recipes:

With no faults – to learn the correct sequences and cycles.

With simulated faults of increasing complexity to be remediated to learn how to respond to

out of normal events.



STEAM IN PLACE (SIP)


A Steam-In-Place (SIP) system is used to repeatedly steam areas of product contact which includes sample ports, flow paths and vessels. A typical SIP system will ensure that all areas that require steaming will have been exposed to live steam for a sufficient duration to kill any harmful materials present or organisms remaining from a previous batch.


Transfer panel or manifold connections are configured incorrectly

Moveable connections at eye or hand level can pose a risk of hazard

to personnel when system is held in pressure

Line and tank pressures are not confirmed before either manways

are opened or valves are manipulated

Temperature alarm bounce (e.g. temperature is measured at 120.99

DegC for one second causing SIP phase to hold)

An Operator or the control software attempts to cool the system

quickly by re-introducing cooling fluids to jacketed tanks resulting

in tanks experiencing heat-stress and creating sudden vacuum

Valves are not closed properly at the end of the process resulting in

a risk of contamination

Incorrect use by personnel of temperature and pressure control

loops (which are commonly used for SIP automation)


Standard Operating Procedure (SOP) training

Knowing how to review field connections for transfer panels etc.

against SOP requirements is essential.

Physical equipment and plant layout training

This includes how to recognize instruments and equipment by

location, type, and state.

Process overview

This is essential to give the why of production and not just the how.

A clear overview gives business and technical context for personnel

that will equip them to prioritize risks and issues that may arise.

Introductory software training

Training on how to log in to and view the human machine interface

(HMI) screens.

Full explanations of menus, buttons and viewing areas.

Training on the piping and instrumentation color conventions that are used – these may vary

from site to site though or follow a corporate standard for color and coding.

Experience in browsing the software to find specific graphics or instrument information quickly

and easily.

Knowledge in how to interpret device status and units of measurement.



WATER FOR INJECTION (WFI)


A Water-for-Injection (WFI) system is used to supply water at correct temperature(s) to a distribution loop that may have numerous use points or “drops”.

It is a system that is used regularly during production including the rinse cycles of the CIP system discussed previously. The diagram below shows a WFI generation unit (WFI Still), a supply tank, and a distribution loop, as well as three points of instrument measurement.


A distribution sequence runs before sanitization has occurred or is complete

Incorrect use by personnel of temperature and pressure control loops (which are commonly

used for WFI automation)

Low flow that may cause pump failure leading to insufficient WFI supply to process systems

Conductivity failure indicating that the WFI purity is unacceptable

Temperature alarm bounce


Process and Control Software overview

It is important for personnel to understand how the WFI system supports multiple process

systems and if the automation software will limit concurrent users and prioritize requests when

that limit is reached.

Introductory software training (In addition to the training described above)

Training on Alarms – alarm categories (quality, safety etc.), alarm types (Critical, Warning,

Advisory, Log etc.), alarm states (active acknowledge, inactive unacknowledged etc.)

Training on responding to alarms and first level troubleshooting responses – acknowledge,

investigate, interpret, respond, escalate etc.

Training on alarm management – alarm rationalization strategy, alarm weighting etc.



CLEAN STEAM


Clean steam generators provide on-demand steam for cleaning of piping and vessels. They are often supplied as a packaged unit, or ‘skid’, with standalone, often Programmable Logic Controller (PLC) based control systems. Steam is generated from a purified water source ready for distribution to usage points. Each of these use points will usually have a steam trap to remove condensate.


Contamination of system at sample ports

Failure of relief valves that typically prevent over-pressure


Mathematics

Number systems and relationships – whole numbers, decimals (esp. rounding), fractions,

alternate base systems

Arithmetic – arithmetic operations on numbers, percentages, square root, exponentiation, and

logarithmic functions

Plane and solid geometry – especially spatial reasoning and geometric modeling

Measurement – esp. systems of measurement, engineering units, and conversion of units

between systems

Mathematical notation – esp. the language of mathematics to express relations and ideas

Mathematical reasoning and problem solving – esp. inductive and deductive reasoning and the

interpretation of results

Elementary statistics and probability – esp. mean, median, and standard deviation

Algebra and functions – equations, patterns/series, and functions

Elementary trigonometry – esp. trigonometric functions

Elementary calculus – esp. exponential, logarithmic functions

Science

Physics – esp. matter and energy and physical interaction

Chemistry – esp. the composition, structure, properties and reactions of matter

Biology – esp. cell biology of mammalian cells (extracellular) and/or microbial cells

(intracellular)



CLEAN COMPRESSED AIR (CCA)


A Clean Compressed Air (CCA) system has a number of purposes as an automation application:

As a pressure source to transfer products or materials

As a means of removing condensate or liquid after CIP or SIP

As a way to quicken batch cycle times by cooling equipment after SIP

As a source of oxygen for aerobic bioreactors

There is limited use of valves or instrumentation for this system but Pressure is measured: Pressure regulation is key for CCA generation and distribution. This is to ensure there is enough pressure to service all use points but not risk over-pressure and risk to personnel or equipment. There are typically no PID control loops for a CCA system.


Contamination of the system by moisture, oil or particulate matter at either instrument

connections or sample ports

Distribution valves 'owned' or 'acquired' by an Operator were not released after use

Compressor overheats due to pressure regulator failure

A surge tank pressure setpoint is lower than instead of higher than the regulator pressures

The surge pressure dead band is too narrow causing the compressor to cycle inefficiently


Personnel who have responsibility to use or oversee a process control system should have an

understanding of the purpose of automation and how Batch Control as well as integration with

a Manufacturing Execution System (MES) is of benefit the more automation is needed to

manufacture products.

For large scale bioprocessing it is necessary to identify what can be quite complex sequences

of control for production recipes. These are coded in the software of the control system in

such a way that batch control can be carried out repeatedly and in a way that separates

equipment from recipes – a huge advantage in efficient equipment use and resource allocation.

A key aspect of training personnel here is to explain the strengths and limitations of automation

as implemented for the control system being used so that personnel understand all of the



manual operations that still need to be carried out (e.g. sampling) and how they are

coordinated with automated operations.

It is especially important that personnel gain such an understanding of automation so that

when using a control system that is highly automated that they always consider the ‘why’ as

well as the ‘what’ of their daily activities. This can prevent simple errors that arise due to simply

‘following instructions’ that may have profound and costly implications.



FORMULATION


Formulation relates to the precise mixing of active and inactive materials. A process control system will typically run batch recipes to create mixtures as well as transfer those mixtures to the particular vessel or station where it will be used or stored.


The inlet flow rate may be too slow/fast

The agitator start/stop trigger heights and/or times may

be incorrect

The air purge duration may not be adequate

The volume of buffer chase may be wrong leading to an

imbalance in the ratio of mixed materials

Temperature control interventions by process operators

may not remedy an issue


One of the most important concepts in automated control loops is modes. The mode determines who, or what, has control over the process/system.

N.B. The way modes are configured for your control system may differ from the descriptions in this series as there are different approaches by different control system vendors.

Other related topics that may need to be covered regarding control loops are:

Principles of Proportional-Integral-Derivative (PID) control

Commonly used PID equations and control system function blocks

Loop control

o Single loop control

o Cascade loop control

Loop tuning

o Proportional term

o Integral term

o Derivative term

o Tuning different types of processes (Fast, slow, integrating, noisy loops)

o Manual tuning

o Auto tuning using standard or advanced software packages

ZTLearning recommend that all personnel who need to interact with a process control system receive training on automated control loops so they can interpret what may be happening in a control loop, diagnose a solution, put the loop into the appropriate mode and resolve the issue before it becomes a costly problem.



HEATING, VENTILATION, & AIR CONDITIONING (HVAC)


The term HVAC covers heating, ventilation, and air conditioning systems.

In the context of bioprocessing these systems are absolutely critical to enable the control of pressure, temperature and humidity within production rooms/suites and buildings. To prevent cross-contamination a slight pressure difference is maintained between adjacent rooms. This is so that when a door is opened the air flow will mostly occur from the “clean” room to the “contaminated” room. The desired direction of air flow is a key design consideration of both building and HVAC design.


Excess humidity can cause condensation in

processing suites and since this liquid can

incubate bacteria and become a source of

product contamination it is critical that the

HVAC system be efficient in reducing and

removing any excess humidity.

Design related: If temperature or pressure

sensors are not located in suitable positions (i.e.

away from high-temperature equipment) then

it may be very difficult for technicians to

“balance” the HVAC system.

Control loop related: If the pressure control of

adjacent rooms is not coordinated and is off by

even 0.05 psi it may take a force of 150 pounds

to open or close a standard door measuring 7

feet x 3 feet!


Training on the ANSI/ISA standard

ISA-71.01-1985: Temperature and Humidity

ISA-71.02-1991: Power

ISA-71.03-1995: Mechanical Influences

ISA-71.04-2013: Airborne Contaminants

The most recent part was released in August 2013 and covers “airborne contaminants and biological influences that affect industrial process measurement and control equipment, electronic office equipment, and data center and network equipment.”

ZTLearning recommends that all engineering and maintenance personnel responsible for the design and maintenance of HVAC systems are adequately trained on this standard.



BIOREACTORS


Cell Culture (or Fermentation) is the major process of upstream bioprocessing. A bioreactor/fermenter vessel is a controlled environment where cell culture processing can take place under controlled conditions.

Cell Culture Processing is the growth and development of a cell line to produce for the benefits of patients products such as antibodies, therapeutic peptides, therapeutic proteins, monoclonal antibodies, vaccines.


Some bioprocesses contain up to 20 sequential operations. An Operator must understand the significance of each and be competent to monitor the process and intervene when necessary.

Bioprocesses typically have a high coefficient of variability (sometimes exceeding 10%). This is often caused by the variability in the amount and viability of culture cells that are inoculated into the bioreactor. Here are some of the possible reasons for this:

Samples may not have been taken at the best time so no action may be taken to alter the environmental conditions until it is too late.

Pressure on the bump/seed tank may have been less than needed, resulting in a slower transfer of the inoculum than desired, during which the cells became oxygen-starved.

The inoculum transfer line may have not cooled sufficiently following sterilization, resulting in undesired heating of the first portion of the transferring inoculum, in turn causing denaturation of some cell proteins and/or cell death.

An Operator may have performed a “late inoculation” in which the culture was depleted of nutrients/oxygen.

These reasons for variability between batches can be reduced by the greater implementation of automation for precise repeatable control but the role of Operator intervention to avoid losses, wastage and inefficiencies - made possible through the application of knowledge and skills – should not be overlooked.


Process overview training

Process explanations of either small scale or large scale cell culture - this is essential to give the

why of production and not just the how. A clear overview can give both the business and

technical context for personnel that will equip them to prioritize risks and issues that may arise.



Introductory software training

Training on how to log in to and view the human machine interface (HMI) screens.

Full explanations of menus, buttons and viewing areas.

Training on the piping and instrumentation color conventions that are used – these may vary

from site to site though or follow a corporate standard for color and coding.

Experience in browsing the software to find specific graphics or instrument information quickly

and easily.

Knowledge in how to interpret device status and units of measurement.

Training on Alarms – alarm categories (quality, safety etc.), alarm types (Critical, Warning,

Advisory, Log etc.), alarm states (active acknowledge, inactive unacknowledged etc.)

Training on responding to alarms and first level troubleshooting responses – acknowledge,

investigate, interpret, respond, escalate etc.

Training on alarm management – alarm rationalization strategy, alarm weighting etc.

Batch software training

Introductory software training to access, navigate and interpret the batch software

How to see what phase(s) in recipe are active

Knowledge of batch states (Held, Aborted, Stopped, Idle) and transient states (Running,

Holding, Aborting, Stopping, Restarting)

How to access and interpret the continuous logic of failure monitoring

How to review the batch control software resource acquisition

How to interpret the bioreactor related graphics and check the ownership of

valves/equipment/units in use to determine what/who else has acquired them to learn why they

are not available

Advanced software training to carry out simulations of bioreactor related recipes:

Running recipes to completion with no faults – to learn the correct sequences and cycles.

Running recipes to completion with simulated faults of increasing complexity to be remediated

by the Operator so they learn how to respond to out of normal events.

The typical operations and phases that run on a 100l bioreactor include:

Inoculum Prep Operation:

Media Line SIP Phase

Media Addition Phase

Post Media Probe Check Phase

Inoculum Line SIP Phase

Inoculation Operation:

Inoculation Phase

Process Operation:

Cell Growth Phase

Titrant Line SIP Phase

Sample Operation:

Sample Phase

Transfer Out Operation

Transfer Out Phase

Operators who have responsibility to monitor the control system and intervene when alarms or out of normal event occur would benefit from training on these operations and phases.



Depending on the depth of learning and simulation required the current best modes of learning include:

Classroom (with each Operator having their own screen)

Virtual Classroom (with each Operator having their own screen)

eLearning – self paced, repeatable, just in time, with detailed Show Me, Guide Me, Let Me Try

simulations

ZTLearning recommend customized eLearning with simulations as a cost effective means of ensuring operations personnel are trained and confident in meeting the complex challenges of Cell Culture Processing.



BIOPROCESS FILTRATION


The three main methods of recovering product in bioprocessing are Centrifugation, Chromatography, and Filtration. Centrifugation relies on centrifugal force and the principles of sedimentation to separate components. Chromatography relies on the differences in size, structure, charge and hydrophobicity (water repelling property) of components. Common forms of chromatography are ion exchange, affinity, gel filtration and hydrophobic interaction.

This article will focus on Filtration, that relies on the size difference or charge effect of components to separate materials in a liquid or gas.


Either natural or synthetic polymers are used in the manufacture of filter membranes and these may be delicate materials. If some filters are allowed to dry out they can be permanently damaged and need to be replaced. Therefore operators typically carry out a pre-wet sequence to wet filter materials while waiting for product processing. Cleaning and sanitizing of the filters may be carried out by chemical means instead of the more harsh CIP/SIP cycles. The operator may oversee filtration control strategies that shift between pressure and flow for the most effective processing. At the completion of bioprocessing filtration there may be some additional flush sequences to extract the maximum volume of product. This is most often the case when dealing with very high value product.

There are many challenges with bioprocess filtration. Filters can become clogged with separated materials. Delicate filters membranes may add special pre-wetting sequences and limiting of differential pressures. Control strategies may need to balance between flow and pressure requirements.


ZTLearning recommend bioprocess filtration training that provides:

Detailed explanations of flow, pressure and differential pressure control strategies

Explanation of a classical filter curve

Ability to manually replace cassette or cartridge filters

Ability to carry out filter integrity tests to ensure:

o No leaks in the system

o The presence of a filter cartridge

o Correct grade of cartridge

o Integrity of cartridge

o Security of seals

Explanation of the types of integrity tests

o Bubble point displacement of water from pores

o Forward flow diffusion of air though pores

o Water intrusion permeation of water through pores



PRECIPITATION


Precipitation typically involves precipitating solid materials from liquid steam. The valuable product can either be in the precipitate, or remain in the solution, and a waste component is precipitated. Precipitation reactions must be very tightly controlled to be sure of success. In particular the process tolerances for both temperature and concentration are very difficult to achieve and typically such reactions are governed by fed-batch operations.

Agitation is also critical to the success of precipitation reactions and variable speed mixers with speed feedback are typically used.

In some precipitation reactions highly volatile or explosive materials for the solute may require explosion-proof designs – and specific training on overseeing such reactions may be needed.

A control system can govern the precise and repeatable control of precipitation reactions. This is significant to production since even a low percentage of product loss during the precipitation process can represent a very large revenue loss owing to process inefficiencies.


While the precipitation fluids may enter a vessel in batch or fed-batch modes a typical batch-fed sequence is shown below.

A process operator will monitor the time and additions and intervene if necessary in the use of temperature control loops. If the heating or cooling media for the vessel are not sufficiently independent from the precipitation vessel there is a risk that the precipitation reactions will be adversely effected by temperature upsets. The control system can be designed to add multiple fluids simultaneously using a ratio control scheme. However if the control loops for temperature control, transition points and concentration ratios have not be commissioned correctly, or the temperature upsets described above occur then a Process Operator may need to intervene.


ZTLearning recommend training that covers:

Elementary chemistry of precipitation

Control loop theory

Control loop modes and interaction via faceplates/detail faceplates of the control system



CENTRIFUGATION


Centrifugation involves the separation of materials through differences in density.

This process can run as either a continuous process or a batch process and be for:

the separation of solids from liquids, or,

the separation of liquids from liquids

Industrial centrifuges for large scale bioprocessing are typically large and support bowl speeds of over 70,000 rpm (revolutions per minute). In some bioprocessing facilities the term fractionation is used to describe the separation, using higher and higher centrifuge speeds, of the nuclei, chloroplasts, lysosomes, ribosomes, and membranes from a cell sample.


While centrifuge controls are typically handled by a dedicated controller designed by the

centrifuge manufacturer the Process Operator will still need to monitor the centrifuge -

especially any alarms relating to high readings from any of the vibration sensors.

High vibration readings are a warning of risk to the safety of personnel, equipment and the

product. In a critical situation the Process Operator must know how to activate an emergency

stop or E-Stop fitted to the centrifuge.

Contamination of the product is another problem that needs to be avoided. Some centrifuges

are fitted with an automated scraper that collects solid materials from the bowl walls at the

end of the centrifugation. This reduces the risk of contamination due to manual intervention.



Elementary physics of centrifugation (i.e. calculation of g-force etc.)

Standard operating procedures relating to the safe use of centrifuges

Training on the controls and/or user interface of the centrifuge if not handled by the main

process control system



WASTE CONTAINMENT AND PROCESSING SYSTEMS


The careful and timely processing of waste substances which often contain proteinaceous material is an essential application (or service) for large scale production to run smoothly. To recap, consider again the figure below illustrating how waste is also produced along with product when using cells as the ‘factory’ to grow the desired product.


Waste containment and processing systems are relatively simple to control by comparison to the other automation applications we have covered in this series.

From an operator perspective there is typically very little interaction with the waste system as the kill system will likely be designed to run automatically with automatic reporting.

From an instrumentation point of view the waste containment and processing system instrumentation will require more routine maintenance to ensure that instruments are both kept clean and calibrated.



The classification of hazardous materials and all gowning/handling SOPs

Emergency protocols in the event of a failure of the waste containment and processing system



CONTROLLED TEMPERATURE ENVIRONMENTS


Controlled Temperature Environments (CTEs) include equipment such as incubators, refrigerators, and freezers. Depending on the form of product to be stored, bottles of product may first be shell frozen in ethanol baths at temperatures as low as -75°C. Shell freezers are then often placed into shell cabinets to facilitate the long-term storage of product.

Lyophilizers (also known as freeze-dryers) are also briefly covered in this article since the term ‘lyophilize’ means to freeze-dry and lyophilizers are typically monitored by the control system. Often Lyophilizer SCADA software does not have a supporting batch report package and the control system is instead used to collect batch report data from the Lyophilizer software.


Controlled Temperature Environments are very simple to control by comparison to other automation applications.

From an operator perspective all interaction is typically manual and these manual activities are carried out as per site SOPs. CTEs are usually stand-alone devices with stand-alone controls but in large scale bioprocessing critical temperature measurements may be sent to an alarm list for an operator to acknowledge and respond to or if designed this way an automated response system.

A Lyophilizer Production Reporting Phase may be used to report to the control system such parameters as the Lyophilizer SIP Mode, Leak Test Mode and Batch Freeze Mode as required by a Lyophilization Batch Report.



An overview of the freeze-drying and storage process for each product

Gowning/handling SOPs for CTEs

Where applicable a walkthrough of both the Lyophilizer CIP Phase and Lyophilizer Production

Reporting Phase (with references to any SOP manual interaction)

Where applicable the contents of a Lyophilization Batch Report and the parameters to review

Emergency protocols in the event of a temperature alarms occurring


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