FILTER AIDS

Is dusty powder handling incompatible with classified area ?

Patrick SELOSSE –OCTAPHARMA SAS

YES! if nothing is done to adjust

-One has been trying for decades to make the use of filter aids somehow “acceptable” with operations of :

- Storage - Weighing - Transfer into production tanks

- Finally, what level of acceptability / risk does one have currently to accept ?

The risks

- Risk to have particles in classified area - Risk of cross-contamination in storage area and weighing rooms - Risk for workers’ health :by exposure to powder

Behavior

Risks: To be or not to be acceptable ?

- What is your behavior during inspections and audits ?

- Have you evaluated business risk

How to tackle the risks?

- Continue to accept such situation - Solve partially the problem with in house solutions - Change our basic technology / Stop using filter aids - Try to solve the problem from A to Z

What to do to get a sustainable solution

- Delivery and storage Dedicate an area to store dusty product ?

- Sampling for QC Build an in house dedicated sampling area for these types of products ?

- Weighing for production Dedicate a classified area in production for weighing operations ?

- Transfer into production tanks How to address all environmental constrains ?

Time to chose Internal/ in-house solution

• Space • Time • What is our core business ? • Costs to built an in-house sustainable solution

External solution Purchase and use of prefilled bags

Why did Octapharma choose an external solution ?

- To save time, money and space - Because filter aids can be managed like filters, not like a chemical

- Because Octapharma found the partner ready to build a cGMP filling unit dedicated to dusty filter aids.

ChangeXplorer solution The first worldwide cGMP filling plant dedicated to filter aids repacking :

An integrated area

Tranfer goods into raw material lock Delivery area

An integrated process Filling of motiv tank

Tranfer into motiv tank Bag opening

An integrated process Bag filling operations

Vibration step Automatic Filling bag in class D

An integrated process Filling in pharmaceutical bags

Storage of filed bags prior packaging Sealing step

An integrated process Final storage

Clean storage area Ready to delivery

NOW

WHAT IS YOUR

CHOICE ?

Thanks a lot for your attention. Any questions?

Speakers

Patrick Selosse

– @mail: patrick.selosse@octapharma.fr

François Rolin

– @mail: changexplorer@orange.fr