Aseptic Fill and Finish

mdi with its wide range of filters with multilayered design, different pore sizes combinations and customize end connections offer high multitude of options backed by more than three decades of expertise in microfiltration, to help you at every stage of development and commercialization to speed up the movement of your biopharmaceutical product candidate into the pre-clinical, clinical setting or into the market.

mdi has a long experience in designing and developing filters for complex formulations including liposomes and nanoparticles, conjugates and adjuvants. Our application development team to understand specific concerns and establish design specifications/requirements and consequently works with a highly qualified group of in house R&D experts to develop customized microfiltration solutions.

Final formulation and aseptic filling of the biopharmaceutical drug may involve a variety of steps such as:

  Sterile filtration of buffers used for formulating a product concentrate
  Sterile Filtration of adjuvants
   Sterile filtarion of drug formulation
   Sterile filtration of air/gases
   Sterile Venting

Micro Filtration in Aseptic Fill and Finish:

Application Area	Application	Filter	Key Product Features
Aseptic Fill and Finish	Sterile Filtration	0.2 µm gamma Sterilizable PES Membrane Capsule Filter AseptiCap- IKL	- Absolute retention - Low Protein Binding - 100% Integrity tested - pH Compatibility: 1-10 - Total traceability: Unique marking on each filter - Individual Certificate of Quality
		0.2 µm gamma Sterilizable PES Membrane Capsule Filter AseptiCap- DKS
		0.2 µm gamma Sterilizable PES Membrane Capsule Filter AseptiCap- LKS
	Pre-filtration	Pleated Polypropylene Capsule Filters ClariCap- DOL	- Very high retention efficiency (99.999%) - High throughputs - Heat stable construction - Non media migrating - Wide chemical compatibility - Biologically inert
		Pleated Polypropylene Capsule Filters ClariCap- LOL
		Pleated Polypropylene Cartridge Filters ClariSure- CPPPA
	Sterile Venting	Gamma sterilizable hydrophobic PVDF 50mm vent filters ClariCap- IVF	- Absolute retention - 100% Integrity tested - pH Compatibility: - Total traceability: Unique marking on each filter - Individual Certificate of Quality
		Gamma sterilizable hydrophobic PVDF capsule filters ClariCap- DVL
		Hydrophobic PTFE 50mm vent filters AseptiVent- ITF	- Absolute retention - High flow rates - High heat stability - 100% Integrity tested - pH Compatibility: - Total traceability: Unique marking on each filter - Individual Certificate of Quality
		0.2 µm PTFE Membrane Capsule Filter AseptiVent- DTL
		0.2 PTFE Membrane Cartridge Filters AseptiSure- CPTF

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