PROVANTIS DISPENSE – UNLOCKING THE BOX

Dean R Hatt

Opening Thought

In a regulated GLP environment, we are sometimes reluctant to change, believing what we have always done, and what we have previously been inspected for, is the safest option

This may not, however, be the most efficient or flexible use of resource, so should be look outside the box ?>

Agenda

Introduction to Dispense (inside the box)

Why look outside the box ? Unlocking the Box Summary

Introduction to Dispense

Dispense is a single, integrated product designed for the management of test materials, from receipt through the various formulations that take place in the course of a typical study.

Batches of test materials and vehicles are logged into the system, with expiry dates, and used in the definition of individual formulations for a study.

Introduction to Dispense

System prompts for weights and volumes, and records weights and data in a fully GLP compliant fashion

Accountability of test materials is achieved by periodically checking the theoretical amounts used against the actual amounts.

All test materials, vehicles, formulation and sample containers, and balances are barcoded To ensure correct containers are used To ensure balances are calibrated prior to use

Introduction to Dispense

System can be used to prepare liquids, fill capsules and make diets and blends

Test materials can be solid, liquids or units It allows direct formulations (weigh test

material + add vehicle), but also serial dilutions and premixes

It uses displacements to calculate amount/weight of vehicle to add (weigh vehicle) or to record weight of vehicle added (QS to volume)

Introduction to Dispense

It has standard (system steps) that are hard coded and require the system to read/check barcodes, request (volumes/weights) and record (weights)

It allows user defined steps that provide textual instructions for the user

Dispense Development Milestones Booking in as a vehicle F5 Key to force a weighing / use a

different ‘similar’ batch of test material F6 Key to record comments against any

step Addition of dates for aliquots Link with In life ‘Provantis’ system Link with Quantos automated weighing

system Link to stored C of A’s

Why Look outside the Box ? When you first demo Dispense, you

want it to replicate what you do in your manual preparation

When you use Dispense routinely, and suddenly you have to record manually, you want your manual proformae to replicate Dispense

Dispense calculations + step-wise process makes sense

Why Look outside the Box ? Dispense data is easily viewable and

provides, through a fully GLP compliant audit trail, an accurate record of the formulation process

Looking outside the box and recording everything on Dispense, provides a one-shop place to record all formulation data

Unlocking the Box

Booking in as a Test Material Restriction: A prepared

solution/suspension can only be used on the same ‘formulation set up’ and if prepared by serial dilution, can only be used once.

Booking any formulation in as a Test Material can allow it to be used on multiple formulation set ups and studies.

Unlocking the Box

Formulation in capsules The system allows a test material to

be weighed into a capsule or a liquid formulation to be used, but not to add a formulation to a capsule

Simply, a formulation is made on Dispense, booked in as a Test Material, and then used to fill a capsule

Unlocking the Box

Customised Labels / Reports As Dispense uses crystal reports,

user defined labels and reports can be produced and standard labels and reports, can be modified to suit the individual client.

A micro label has been created without barcodes and Dispense-specific information and approx 50% of size, to allow labelling of samples sent to third parties.

Unlocking the Box

Packing for Inhalation studies Dispense is designed to prepare a

formulation, however, it can be used to record steps of any process

Here, the formulation definition is built up around a weigh test material step using user defined steps with the operator recording data using the F6 key

Unlocking the Box

Unlocking the Box

Intra-nasal Device Testing This takes things one step further

with no weighings in the definition Here, the formulation definition is

built up using just user defined steps with the operator recording data using the F6 key

Unlocking the Box

Unlocking the Box

Excipient as Test Material There are times when an excipient

needs to be a test material e.g Methylcellulose, when making 1% (w/v) Methylcellulose, with the water as the vehicle

However, it is sometimes easier to add an excipient e.g Tween 80, to a final formulation, as a test material

Unlocking the Box

Addition of Vehicle to Pre-weighed Drug Here, the exact quantity of test material

has been provided in a container and to weigh it out would cause loss

A calculation is made manually as to how much vehicle needs to be added, and this is recorded on Dispense

This formulation can then be booked in as a Test Material if subsequent serial dilution is needed.

Unlocking the Box

Unlocking the Box

Addition of Analytical Diluent Dispense allows for preparation of a

formulation and subsequent sampling ,but does not have ability to dilute a sample

Here, you can see how we utilise Dispense to record the weight/volume of diluent added to a sample

Unlocking the Box

Unlocking the Box

Addition of Analytical Diluent This can be taken further by having

multiple dilution steps all the way down to the analytical range

Unlocking the Box

Addition of Analytical Diluent This can be taken further by having

multiple dilution steps all the way down to the analytical range

You can also prepare standards and QC’s using the system

Unlocking the Box- Summary Allows easy access to all formulation & analysis

data Fully GLP compliant Can use the system for items it was not designed

for Booking in as test material Liquids in capsules Customised labels Inhalation packing / device testing Excipients as test materials or vehicles Use of pre-weighed test material Sample dilution and analytical standards/QC’s Anything else !

Unlocking the Box- Summary We would however like Dispense to

be able to do some of these things from within the box !

Ability to Book in as a Test Material with a simple key stroke.Ability to dilute a sample with a simple key stroke

Unlocking the Box – Final Thought