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Farmalyse
BV - The Company
FARMALYSE & BACTIMM - CONTRACT LABORATORIES
FOR PHARMACEUTICAL AND MEDICAL DEVICE ANALYSIS
Our core-business is the Chemical Pharmaceutical Investigations
for Analytical Method Development, Quality Control and Stability
Studies & Pharmaceutical and Medical Device Microbiology.
DISSOLUTION – BIOBURDEN – FRIABILITY
– ENDOTOXINS – RESIDUAL SOLVENTS – VIABLE COUNT
– HPLC – STERILITY – VALIDATIONS – CLEAN
ROOM TECHNOLOGY – PARTICLE SIZE – MEDIA – STABILITY
TESTING – ENVIRONMENTAL MONITORING – ASSAY –
IRRADIATION STERILISATION VALIDATION – IDENTITY –
PRESERVATIVE EFFICACY
Staff
With our focus on Pharmaceutical Analysis, staff at Bactimm
and Farmalyse specialise in the particulate needs of this demanding
industry. Current, mainly graduated, staff have between them considerable
experience in a wide variety of pharmaceutical applications for
our broad client base. All key members of our Management Team
(n=3 pharmacists; n=2 MSc chemistry and pharmacy and n=1 PhD biochemistry)
are technically based, ensuring a knowledgeable adequate response
to your inquiries.
Technical Expertise
In order to ensure Bactimm and Farmalyse being successful we
have expertise in all areas of separation technology, spectroscopy,
physical tests (dissolution, particle size analysis) and associated
computing required by these areas. It is company policy to maintain
this expertise through training and further acquisition of the
appropriate skills.
Bactimm and Farmalyse combine all pharmaceutical analysis services
necessary for routine quality control of pharmaceuticals and Medical
Devices.
During the last 4 years we focused on import/export companies
that outsource pharmaceutical production to countries outside
the EU – Farmalyse & Bactimm prove to be adequate partners
for these companies with respect to the paragraphs 6.4.1 and 6.4.2
of Annex 16 (on Batch Release) to the EU GMP.
Scope and Level of Quality Systems & Services
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Analytical services are performed according
to ISO 9001:2000 and GMP-GCLP; |
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Independent QA-teams; |
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Provision of Pharmaceutical Media for Quality Control Departments
– media are produced under GMP licence. Our incoming
media check is therefore 100%; |
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Farmalyse: focus on chemical analysis (Stability
Research, Particle Size by laser diffraction, GC, HPLC, UV
& Dissolution) – Specialisation: Analytical Validation
Studies for Regulatory Affairs including Drug Master File
screening; |
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Bactimm: focus on microbial analysis (endotoxins,
bioburden, sterility, preservative efficacy, disinfectant
activity testing & biological assays) – Specialisation:
GMP Training of staff and Validation studies for sterilisation
processes (in particular: Gamma Irradiation Sterilisation); |
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In general: years of experience and trained staff has resulted
in adequate through put times for Routine Quality Control
of pharmaceutical preparations. |
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Us
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Address
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Farmalyse BV |
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Pieter Lieftinckweg 2, |
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1505 HX ZAANDAM, |
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The Netherlands |
| Tel. |
+31 75 612 36 66 |
| Fax |
+31 75 612 40 77 |
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