Flexible containment solutions for preclinical thru scale up processes

Transcription

1 Flexible containment solutions for preclinical thru scale up processes

2 Our presentation today 1) The focus will be on the use of flexible containment while handling powders 2) Small scale examples of quick deployment solutions and ease of use to achieve high containment 3) Combining flexible containment with transfer systems to move product and tools thru containment 4) Containment performance 5) Development process train example

3 Lab top to full scale Table top flexible isolator with self supporting frame for easy deployment any where Scale up capacity for all sizes and function. Example is a 12 dia vessel used in development and production

4 When to use containment? Minimal containment and PPE with compounds identified as non potent Performing the same tasks in isolation when the compound toxicology is not complete or has been identified as potent / cyto toxic

5 But Flexible Containment can be used anywhere Flexible systems provide a fast and effective option for high containment.

6 Simple solutions in small scale Simplistic and effective containment The equipment can still be operated without the containment if desired

7 Typical solutions in small scale Portable and temporary Lightweight No utilities Collapsible support frame Easy disposal Weigh Scale, Press and Titrator

8 LEV and Hoods Moves the powder to a filter and then then containment is still needed Does not protect product from contamination Face velocities could pull valuable product away Simple flexible isolator used instead of fume hood or laminar flow hoods but can also be installed in that space to give isolation

9 The static vs dynamic question Containment Flexible containment CPT can be < 30.0 Ng/m3 Concern over systems dependent on operator skill vs automation and achieving consistent results Is the question containment performance or risk? Risk Process, Potency, and Quantity Transfer points and number of transfers will use same technology Unlikely failure of a flexible wall torn or cut Dynamic system offers belt and suspender approach Cost CapEx costs typically the lowest with flexible systems Transfer method will influence the cost Consumables cost comparison over time Cleaning and validation vs. disposal comparison How should we think about ergonomics?

10 Transfer in / out of containment Bag In / Bag Out or Sleeve to transfer out RTP and RTP Bag Out Split butterfly valve Containment Contamination control Sterile transfers Flexible pass box

11 Containment performance example Conical Mill example Static flexible isolator Mill is located outside of the containment zone Contain the source which is inlet and discharge Contain the material to be bagged in for feeding

12 Containment Performance example

13 Containment criteria Process scenario CPT * Balloon flexible isolator for small scale isolators using an integral Bag Out sleeve Flexible isolator in OSD process using a transfer bag and multi-use Bag In / Bag Out system Flexible isolator in OSD process using an RTP transfer system (container in a container) Flexible isolator in OSD process using a typical HC SBV to transfer powder via a powder transfer bag Flexible isolator using a zipper or pass box system One process step only Process requiring zippers to open multiple times <20.0 ng/m3 <50.0 ng/m3 <100.0 ng/m3 <1.0 µg/m3 <1.0 µg/m µg/m3 *CPT are typical results reported from surrogate testing

14 Deploying flexible systems Contains at the source forming a closed process Flexible designs are easy to retrofit to existing processes cgmp environment is created inside the isolator Can use all transfer technology for moving product and tools in an out of containment Some designs will require the equipment to be placed fully in the isolator while other designs can contain the powder process and reduce cleaning of equipment Utility connections are made easily for electric, air, N2, water, etc

15 Deploying flexible containment Balloon type Isolator 1) Defined as a 6-sided isolator 2) Access using BIBO, SBV, zipper, etc 3) Mount isolator to frame or fixture 4) Load tools and products and then close 5) Complete processes 6) Transfer tools and products out 7) Seal based on the transfer system 8) Dispose of isolator The size and operation is limited by the transfer system used Balloon type Isolator 1) Defined as a 5-sided isolator using a pan or flange to seal 2) Access using BIBO, SBV, zipper, etc. 3) Equipment is loaded onto pan or is in place 4) The flexible isolator is installed using a gas tight trim system If tape is used containment can be compromised 5) Complete processes 6) Transfer tools and products out 7) Seal based on the transfer system 8) Perform a WIP or cleaning process 9) Remove trim and dispose of isolator

16 Deploying flexible containment Balloon type flexible isolator to maintain containment and dispose self-contained type of system Pan type with gas tight trim system

17 Using flexibles Design options

18 Integrated process room

19 Integrated process room Negative pressure system with breach control to contain multiple processes

20 CMO Development Lab CPT < 50.0 ng/m3

21 CMO Development Lab CPT < 50.0 ng/m3

22 CMO Development Lab CPT < 50.0 ng/m3

23 CMO Development Lab CPT < 50.0 ng/m3

24 Questions???? Thank you