Hygienicum Graz
GMP-certified microbiological laboratory testing
Hygienicum, Institute and Competence Center for Micro- and Molecular Biology, has a GMP-certified department for pharmaceutical quality control according to Ph.Eur with state-of-the-art infrastructure around an isolator GMP Class A as well as state-of-the-art systems such as the endotoxin test system using recombinant factor C (rFC).
Our GMP certificate includes the following test methods:
Ph. Eur 2.2.44 Total Organic Carbon In Water for Pharmaceutical Use
Ph. Eur 2.6.1. Sterility Testing gemäß Ph. Eur
Ph. Eur 2.6.12. Microbiological examination of non-sterile products: microbial enumeration tests gemäß Ph. Eur.
Ph. Eur 2.6.13. Microbiological examination of non-sterile products: test for specified micro-organisms
Ph. Eur 2.6.14. Bacterial endotoxins
he portfolio is supplemented by non-GMP tests for cosmetic products, which include the microbiological preservation challenge test, tests for the absence of specified germs and the microbial count / counting and detection of aerobic mesophilic bacteria as well as the counting of yeasts and molds.
In addition, other in-house methods are available for medical device control, bioburden testing, germ and mold identification and evaluation of microbiological environmental monitoring under non-GMP.
Overview Portfolio:
- Sterility testing
- Testing for endotoxins
- Testing of non-sterile products for total plate count (TAMC/TYMC)
- Testing of non-sterile products for specified germs
- TOC analysis
- Validations / Verifications
- Bioburden analysis
- Germ / mold identification
- Microbiological environmental monitoring
- Preservation load test
For special inquiries, please do not hesitate to contact us at pharma@hygienicum.at.
Hygienicum GMP approval certificate: Operating license
Hygienicum GMP Certificate: Certificate
Your partner in Graz:
HYGIENICUM GmbH, Institute for Food Safety and Hygiene
Robert-Viertl-Straße 7
A-8055 Graz-Straßgang
Austria
Tel. +43 316 69 41 08 - 0
Mail: pharma@hygienicum.at
Commercial Register: Graz FN385462g
UID no. ATU 67452133
EORI number: ATEOS1000089395
Opening hours (except public holidays in Austria):
Mon. - Thu: 08:00 a.m. to 04:00 p.m., Fri: 08:00 a.m.- 01:30 p.m.
Hygienicum - other services
An overview of our services:
- Food and cosmetics laboratory (chemical, microbiological, molecular biological, sensory)
- Assessment according to § 73 LMSVG 2006
- Labeling inspection (international)
- Consulting (hygiene, food technology, quality management)
- Audits (IFS, BRC, ISO 22000 FSCC - Certificate Quality Austria)
- Pest control
- Research and development
- Harmlessness testing
GBA Group Pharma
GBA Group Pharma is one of the largest and most experienced service providers in the European pharmaceutical and biotechnology sector. Under one roof, the group supports the pharmaceutical process from drug development to distribution, from preclinical to clinical services, including analytical services, provision of clinical trial supplies, central laboratory services, QP services and support for release processes and the import and export of approved products.
