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PHORUM

Fill Finish

Overview

In Fill Finish (FF) you will find representatives of the world’s top sterile filling operations developing solutions to some of the most intractable technical and regulatory challenges.  Members are now rolling out industry approaches to environmental monitoring and particle risk management; working together on rapid micro adoption and reconciling some of the critical challenges that Annex 1 brings to final filtration integrity testing and isolator disinfection.

The FF mission is to develop and implement best practice processes in drug product operations.

 FF  collaborates to develop and implement safe, predictable, lean and agile processes in drug product operations that biopharmaceutical pipelines need now and into the future and  has strong representation of the top sterile filling operations in the world, both drug manufacturers and CMOs.

Phorum members have shared goals

  • Agree how to demonstrate control levels to agencies, in an effective way
  • Move new techniques forward in our risk averse environment
  • Work together to develop error proof, highly flexibility operations

The current FF collaboration program is targeting a number of transformational operational improvements.  While some of these benefits are easy gains for members, they also recognize that in our regulated environment it makes sense to move together.  For this reason, in many cases companies plan synchronized adoption to change the landscape that regulators see across the industry in one go.

Benefits include:

  • Reducing barrier breaks and isolator operating costs by optimizing settle plate use and even replacement with new rapid micro technologies.
  • Harmonizing on the best biopharmaceutical Environmental Monitoring (EM) deployment practices, to ensure the very best control and investment profile in existing and new facilities
  • Reducing lyophilization scale-up and transfer times, and allowing for better optimization of run times and capacity by making the application and use of lyo computer models a reality at commercial scale
  • Reducing particle contamination of conventional elastomeric stoppers, by promoting a strong industry voice and engaging with suppliers and other parties in a constructive way
  • Providing clarity and confidence on particle classification by product type for visual inspection operations, with the use of a new harmonized risk based methodology.

News

Apr 2019

Articles

Companies poised to follow ARMM recommendations

The Advanced and Rapid Microbial Methods (ARMM) team set out a clear case for modernizing Environmental Monitoring (EM) in grade A settings:[..]

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Feb 2019

Articles

How to achieve the ‘Goldilocks’ amount of environmental monitoring

Regulators require a risk-based approach to environmental monitoring (EM)… but they give no clear definition of what “risk-based” actually means. The aim[..]

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Feb 2019

Articles

Join BioPhorum at BioProcess International events

We have partnered with BioProcess International for more than five years. In that time, their conferences have provided platforms to socialize the[..]

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Dec 2018

Articles

2018 highlights

BioPhorum’s mission has always been to make the journey for tackling industry challenges better, faster and cheaper for members. By helping you[..]

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Dec 2018

Articles

The Fill Finish Phorum – tackling issues around the operation of isolators

From glove management and cleaning/disinfection to regulator expectations and technology solutions, the operation of isolators has become an increasing concern among members.[..]

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Oct 2018

Articles

Best practice in the use of a dye ingress test method in CCIT

BioPhorum has recently published an article called Dye Ingress Methods for Container-Closure Integrity Testing: An Industry Position Paper

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Oct 2018

Articles

PUPSIT converted to SFQRM

At October’s PDA/BioPhorum meeting in Berlin, it was agreed that the Pre-Use Post-Sterilization Integrity Testing (PUPSIT) consortium would be renamed Sterile Filtration[..]

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Oct 2018

Articles

Providing clarity when classifying visible particles

The BioPhorum Particulate Control Workstream has developed a standardized methodology and risk classification tool for particle classification in biopharmaceutical parenteral products.

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Oct 2018

Fill Finish News

VI Risk Classification Tool PoC September 2018

Document download

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Aug 2018

Articles

FF19 endorses development of an industry validation method for existing rapid sterility technologies

At the latest Fill Finish meeting in Roche’s Hillsboro facility, member companies compared efforts to use technology to reduce release times.  Among[..]

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May 2018

Articles

Companies encouraged to adopt more appropriate measures of stopper particle contamination

The Stopper Quality team has identified a new methodology by which biopharmaceutical companies can measure levels of particulate contamination on elastomeric stoppers[..]

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Sep 2017

Articles

Driving Lyo quality and productivity

A recent meeting with Purdue University's LyoHUB consortium in Cambridge, MA provided a forum to find synergistic and coordinated collaborative opportunities. 

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Sep 2017

Articles

Container closure integrity control versus integrity testing during routine manufacturing

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Aug 2017

Articles

BPOG’s offering is enhanced as new members join

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Aug 2017

Articles

Real-time contamination risk-management in drug product moves a step closer

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Jun 2017

Articles

How to gain benefits from lyo modelling

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Feb 2017

Articles

Lyophilisation workstream plan 3 good practice guides

The Fill-Finish Lyophilisation (Lyo) workstream plan to write publications which will facilitate adoption of good practices.  Following constructive discussions with Purdue University's LyoHub consortium, the[..]

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Feb 2017

Articles

BPOG in the Press

The BPOG workstreams have gained a lot of coverage in the industry press in recent months with topics ranging from Technology Roadmapping[..]

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Dec 2016

Articles

Bumper Set Of Deliverables for Fill Finish in 2017

Since this time last year all seven workstreams have had valuable change missions and 2016 has largely been about teams exploring what[..]

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Oct 2016

Articles

Positive start to regulatory engagement for Technology Roadmapping and Lyo modelling

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Aug 2016

Articles

Future-Proofing Fill Finish

Fill Finish core team used their 12th face-to-face meeting to lay the groundwork for the drug product component of Technology Roadmapping. The[..]

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Aug 2016

Articles

A harmonised industry way to determine visible criticality by product

The Fill Finish, Particulate Control team are developing a standard way we can each assess particle risk and set the classification based[..]

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Aug 2016

Articles

Lyophilisation team target the qualification of commercial scale models

Lyophilisation cycles can take many days to complete and the only real way to test parameters and to see if the process[..]

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Apr 2016

Articles

Cook Pharmica Joins BPOG

Cook Pharmica joins the Drug Substance and Fill Finish Phorums

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Apr 2016

Articles

Establishing qualification pathways for Rapid Micro

It has long been acknowledged within the bio-pharmaceutical industry that our environmental monitoring technologies are old, time consuming and inflexible. New Rapid[..]

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Dec 2015

Articles

Fill Finish Leaders Target Particle Risk Links and Small Flexible Fillers

During the recent Annual Review at Fill Finish 10 (FF10) in Puerto Rico, the Fill Finish Leaders committed to two audacious missions.[..]

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Dec 2015

Articles

Harmonization of Environmental Monitoring

Following its launch in April, the Environmental Monitoring in a Modern Drug Product Facility (EM in DP) workstream formally started with a[..]

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Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

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