Sterile APIs

High performance microfiltration technology

Euticals manufactures bulk sterile APIs to cGMP standards in Bon-Encontre and Tonneins. Euticals provide a complete range of synthesis capabilities for sterile API projects, from raw materials through regulated early and late stage intermediates to bulk APIs. We also offer advanced building blocks based on proprietary, leading technologies that can be used in all of these synthesis situations. Our sterilization capability can be integrated with API production or operate as a separate outsourced step for companies that do not have bulk sterile facilities or who may need additional capacity. Our Tonneins location was expanded in 2002 to include a sterile pilot plant and a Class A cleanroom handling facility. Our Isolated facilities are located on sites with a range of chemistry capabilities that are flexible in size and scope and even allow the handling of hazardous reagents in chemical syntheses. This allows us to integrate API synthesis, whereby the overall synthesis and process chain can be made more efficient, such as final purification during the sterilization process. 

Microfiltration advantages

At Euticals, sterilization is accomplished by high performance microfiltration. This technology is often used with powder, which is dissolved, filtered and crystallized. Microfiltration is fundamentally different from traditional sterilization methods in that it is non-destructive. We have experience in precisely controlling the physical properties of the final product, with many options available.

Quality is assured

Our sterile API teams have more than a decade of experience with creating the appropriate conditions for the media fill and process validation even for very difficult to handle or sensitive products. Our QA follows strictest FDA, ICHQ7A and ICHQ1A guidelines and our QC is able to determine all relevant parameters. Our plant, especially in the aseptic processing area, uses a system of airlocks and cleanroom zones from class D through class A in the product zone.

  

STERILIZATION
TECHNOLOGY

Moist heat

Dry heat

Irradiation

Aseptic filtration

Principle

Autoclave 121°C
15 min

Autoclave 160°C
120 min

yRay/electron
beam > 25 kGy

Dissolution/filtration
Crystallization

Form

Aqueous product

Dry powder
Non-aqueous liquid

Dry powder
Non-aqueous liquid

Dry powder
Non-aqueous liquid

Strength

Closed vessel
Cost-efficient

Closed vessel
Cost-efficient

Closed vessel

2 in 1 step
stability of API
Impurities control

Weakness

New impurities

New impurities
Time consuming

New impurities
Apparatus cost
Dark packaging

Manipulation
Packaging Step

Sterilization

   
Destructive sterilization

Chemical purification
and sterilization


Euticals S.p.a.
- V.le Milano, 86 - 26900 Lodi | P.I. & C.F. 07254610152 | Cap. Soc. € 40.828.466,30 iv - R.E.A. 1851470 Isc. Reg. Imp. di Milano | Notice >