For the last 20 years
we have been supporting you
in developement and quality control
Supporting you in designing to marketing your product is our priority, through 8 technical platforms and close to 100 staff whose sole goal is the success of your projects that we meet your needs.
2 sites in France: 1 site specializing in RMN based in the Parisian area and our primary site based in Provence.
The combination of multiple expertise positions Albhades on a comprehensive analytical offer comprising mineral chemistry, organic chemistry, RMN analyses, microbiology, cellular biology, mechanical tests, stability studies and toxicology.
Our services in Microbiology
From leading method validations to release checks, the microbiology laboratory is COFRAC approved for many analyses:
- Microbial counts
- Presence/Absence
- Specified germs
- Sterility checks (in clean room)
- Challenge tests
- Antibiotics titration
- Bactericidal, fungicidal
- Water control (process & sanitary)
- Bacterial and fungal identifications
- Disinfector washers
- Autoclaves
Read the COFRAC approved analysis.
Our services in Cellular Biology
Specializing in the evaluation of in-vitro toxicity, several tests were performed on this platform:
- Endotoxins method D (2.6.14) by kinetic colorimetrics
- Cytotoxicity (NF EN ISO 10993-5, NF EN ISO 10993-12)
- Irritation test (ISO 10993-23)
Read the COFRAC approved analysis.
Our services in Organic Chemistry
An installed base of GC and HPLC units fitted with miscellaneous processors and sensors enables most organic molecules to be quantified and identified:
- UHPLC-UV-ELSD-QTOF / HPLC-DAD-FLD / HPLC-DAD-RID / HPLC-UV
- GC-FID / GC-MS / GC-MS/MS
- IR / UV-Visible
- Karl Fisher or colorimetrics
- COTmeter
Albhades also supports you in the research and identification of unknown compounds by using high resolution mass spectrometry, particularly when producing extractible or releasable profiles.
Our services in Mineral Chemistry
Using the most advanced equipment, the laboratory is able to dose all the elements, regardless of their concentration and the matrix to be analysed:
- IC
- ICP – OES / ICP- MS
- SAA Oven / Flame
- ICP-MS / ICP-OES
- SAA Oven / Flame
- Oxygen bomb
- Ultrawave microwaves
- Kjeldhal distiller
- Kjeldhal mineralisation unit
- Dissolutest
- Aw-metre
- Particle counter
- Mastersizer 3000 MALVERN laser granulometer
Our services in RMN
The Romainville site, dedicated to RMN analyses, is the only French laboratory to run BPF-certified RMN and COFRAC approved analyses.
COFRAC.
3 400 MHZ RMN spectrometers, used for:
- Characterization of your products
- Identification of impurities
- Absolute purity measurement
- Determination of concentrations
- Analysis of complex mix(es), followed with (bio)reactions
The assets of RMN:
- Analyses of organic and inorganic compounds
- Universal technique
- Quantitative
- Nos-destructive
- Robust
Our services in Toxicology
Albhades has a team of toxicological pharmacists helping you in producing and writing up your BEP, BER, TRA (consulting…):
- Biological evaluation plan (BEP) (ISO 10993-1, ISO 14971)
- Chemical characterization (NF EN ISO 10993-12, NF EN ISO 10993-18)
- Toxicological risks assessment (TRA) (NF EN ISO 10993-17)
- Biological evaluation report (BER) (ISO 10993-1)
Product storage
- Storage and tests performed on the same site
- Global storage volume close to 500m³
- Climatic rooms up to 50m³
- Multiple and customizable conditions (ASTM F1980, ICH)
- Storage areas under permanent surveillance with alarm systems: Temperature & Hygrometry
Analyses of your products
- Stability check of an active substance, a human or veterinary drug over its lifetime (to determine its use-by date or over its lifetime)
- On-going stability: stability monitoring of the batches manufactured (BPF)
- Development and validation of the methods
- Measurement of analytical, physico-chemical and biological parameters, selected
- ICC or extractables/ releasables
- Packaging integrity: sealing, sterility, evaporation, test in use…
- Releasing of certain compounds making up the packaging: labels, ink
- Forced degradation
- Photostability as per ICH Q1B
- Accelerated ageing to assess the effects of time on the integrity of the sterile barrier formed by the packaging of medical devices
Vous accompagner de la conception à la commercialisation de votre produit est notre priorité, c'est avec 8 plateaux techniques et plus de 100 collaborateurs ayant pour seul objectif la réussite de vos projets que nous répondons à vos besoins.
2 sites en France : 1 site spécialisé en RMN basé en région parisienne et notre site principal basé en Provence.
La multiple combinaison d’expertises positionne Albhades sur une offre analytique complète comprenant la chimie minérale, la chimie organique, les analyses RMN, la microbiologie, la biologie cellulaire, les essais mécaniques, les études de stabilité et la toxicologie.
Services of the mechanical laboratory
The mechanical laboratory checks the quality of your packaging, porous, non-porous used for primary packaging (blisters, sachets, IV pockets, plastic container...) according to standard ISO 11607-1.Inspection visuelle : ASTM F1886 / F1886M.
Visual inspection: ASTM F1886 / F1886M.
Sealing tightness: ASTM F3039 method A / ASTM F1929 method A
Sealing width: NF EN 868-5 appendix
Sealing force: ASTM F88 / F88M / NF EN 868-5 Annex D
Bubble test: ASTM D6653 / ASTM F2096 / ASTM D3078
Nos prestations en Microbiologie :
De la réalisation des validations de méthode aux contrôles libératoires, le laboratoire de microbiologie est accrédité COFRAC sur un grand nombre d'analyses.
Equipé d'une salle blanche, nous pouvons réaliser des essais de dénombrement aux contrôles de stérilité :
- Microbial counts
- Presence/Absence
- Specified germs
- Contrôles de stérilité
- Challenge tests
- Antibiotics titration
- Bactericidal, fungicidal
- Contrôle de l'eau
- Légionelles
- Bacterial and fungal identifications
Nos prestations en Biologie Cellulaire :
Specializing in the evaluation of in-vitro toxicity, several tests were performed on this platform:
- Endotoxines méthode D (2.6.14) par colorimétrie cinétique)
- Cytotoxicité quantitative et qualitative
- Irritation test (ISO 10993-23)