NextPharma Technologies Belgium
Braine-l'Alleud, Belgium
Services & Capabilities
Sterile Product Development Centre (SPDC)
All clinical materials will be manufactured in accordance with the requirements of US FDA, EMEA and other regulatory agencies.
Read more about our SPDC
Product Development Services
- Cytotoxic or high potent non cytotoxic freeze-dried and solutions
- Sterile parental forms
- Analytical and stability studies for products
- Cytotoxic clinical materials preparation and packaging
Sterile Cytotoxics
Cytotoxics - lyophilisation and solutions
Our Belgium site, Braine l'Alleud, has extensive know how in contract manufacturing, packaging and control of cytotoxic products gained over more than 15 years (1993).
NextPharma has initiated a programme for the implementation of FDA status, including extensive expansion and upgrading of our cytotoxics production capacity and capabilities.
Additionally, we are focussing on the development of new delivery dosage forms.
Production (capacity p.a.)
| Sterile cytotoxics | vials 3 to 100 ml with filling volume | 8 Mio. vials |
| from 1 to 100 ml |
Services & Equipment
- Dedicated production + QC in a restricted zone
- Washing tunnel for depyrogenisation
- 1 Farmomac F57 filling machine
- 6 Freeze-Dryer total 90.0 sqm
- 1 capping machine + 1 external decontamination machine
- Filling under class A with closed RAB’s in class B area
- 100% visual inspection: manual or semi automatic
- Specific visual inspection for Japanese market
- Labelling on line + packaging
Sterile injectables
- Non high potent product in vials: freeze-dried and solutions
| Sterile injectables | vials from 1 to 100 ml with filling | 4 Mio. vials |
| volume from 1 to 100 ml |
Service & Equipment
- Dedicated production area
- 1 Washing tunnel for depyrogenisation
- 1 IMA F400F filling machine
- 1 Freeze dryer Telstar 11 sqm
- 1 capping machine IMA ALU 400
- Filling under class A in class B area
Ampoules
- Solutions
| Ampoules: solutions | ampoules from 1 to 25 ml | 25 Mio. Ampoules |
Service & Equipment
- Dedicated production area
- 1 Bausch & Stroebel filling machine AFV6010 in class A conditioning
- Aseptic filling or final sterilization
- 1 automatic visual inspection
- Labelling and packaging
Sterile eye drops
| Sterile eye drops | plastic bottles from 2 to 50 ml | 16 Mio. plastic bottles |
Service & Equipment
- Dedicated production area
- Compounding up to 2000l stainless steel vessel followed by sterile stainless steel vessel or Stedim disposables sterile plastic bags
- 1 filling machine Farmomac under class A in class B conditioning with different devices
- Labelling outline with sleeve
- Packaging line
Microbiology
- Complete microbiological laboratory with separate HVAC system
- Sterility test in class A
- Environmental monitoring
- Microorganisms identification
- LAL testing
Analytics
- 2 separate laboratories: general & cytotoxic
- Analytical: API (Ph Eur, USP, JP) Finished products
- HPLC, GC, UV SR spectrophotometer
- Sub-visible particules testing
- Validation and stability tests/storage
Key Figures
| Site Area | 55,000 sqm |
| Built-up Area | 20,000 sqm |
| GMP Production Area | 7,094 sqm |
| QC & Microbio Laboratories | 550 sqm |
| Warehouse Capacity (Pallet Places with different temperatures) | 6,400 |
| Warehouse / Dispatch Area | 3,200 sqm |
| Administration | 1,050 sqm |
| SPDC | 1,400 sqm |
Site Info
NextPharma Braine l'Alleud
Rue de la Papyrée 2-6
B-1420 Braine-l'Alleud
Begium
Phone: +32-2-386 12 11
Fax: +32-2-385 17 82
General terms and conditions
Conditions Générales d'Achat
(PDF Download)
Conditions Générales de Vente
(PDF Download)
Your contact persons:
Business Development
Dr. Hermann Osterwald
Phone: +49-551-382-105
Fax: +49-551-382-111
e-mail: hermann.osterwald(at)nextpharma.de
Project & Tech. Transfer Director
Yves Buelens
Phone: +32-2 8010 501
Fax: +32-2385-1782
e-mail: yves.buelens(at)nextpharma.be