AES CHEMUNEX is ISO 9001:2000 certified for the design, manufacturing and sales of
reagents, instruments, consumables and materials for microbiology laboratories.
As to guarantee the quality and the performance of our culture media, we process and
control them according to the specifications described in the European Pharmacopoeia
(6th edition).
The environment process (hygiene, pressurisation, temperature, humidity…) undergoes a
harsh and continuous monitoring.
Preventive servicing is carried out on the processing machinery. Measurement and test
control appliances are calibrated and adjusted to the standard reference.
A highly qualified staff and clearly described procedures make the process easily accessible
to each employee.
Our media go through physical and chemical controls (pH, volume, appearance…) during process and before final validation of batches. Qualitative and quantitative microbiology tests are carried out on each batch before testing their efficiency on stability, fertility and reactivity. Micro-organisms strains used for fertility tests are the ones specified by the European Pharmacopoeia.
A special file is available, on request, summering up all the stability validation tests after transport.
Each one of our packs is sealed with a standard label as a warranty of inviolability (Tamper
proof label). On this label figure the following data:
• Name of the product, packaging and quantities
• Storage temperature,
• Reference, Batch number, expiry date.
A quality control certificate known as “detachable” and “self-adhesive” is composed of the
following information:
• Name of the product, packaging and quantities
• Reference, Batch number, expiry date and pH.
• A conformity statement notifying that the quality control has been carried out following
a Standard Quality Control Sheet «QCP» whose auditing index is referred to.
An update of the latest QCP version is easily accessible through our website or just by contacting our microbiology technical department. To have access to the QCP via the web site you will be given a password when you first login. From then on wards an e-mail will be sent to you when a modification occurs.
Moreover, the label is composed of 12 stickers on which figure the following details: Name of product, batch number, and expiring date.
QCP and control certicate management
A vast majority of our media have now detachable self-adhesive quality control certificate that
you can find on their packaging. This new form of certificate will firstly shorten the time spent
on controlling the different statements and secondly minimise the volume of papers filed.
The self-adhesive certificate refers to our protocol and control certifications, known as
Quality Control Protocols (QCP). These protocols carry an auditing index up dated when
the protocol is modified (new packaging, use of new micro-organism strains…). The selfadhesive
label gives the variable data belonging to the batch (ie: number, pH, expiring date).
The QCP lists all the other details of the control: appearance, sterility, fertility… By sticking
the quality control certificate to the QCP it refers to, all the details of the data controlled on
the batch are then filed. The self-adhesive certificate guarantees that all the different
steps of the procedure listed on the QCP have been validated before releasing the
batch.
Any modification given to the QCP by AES CHEMUNEX, entails a revision of the auditing
index. This modification then automatically appears on the self-adhesive certificate of the
newly controlled batches. As to keep your paper work up dated you then just need to obtain
the new version by contacting our microbiology technical department (phone, mail, fax) or
logging onto our website: www.aeschemunex.com
To get access to the QCP on our website you need to register (free service) on our on-line
service sheet. This formality not only allows you to get access to the QCP but also to the
media’s technical sheets, and most importantly to be informed by mail that a QCP has been
revised. This service will help guaranty the follow-up and up date of your media files.
In parallel of our system QCP/certificates stickers, we offer to you via our on-line service a new tool allowing you to print by batch a quality control certificate including raw data from our quality control laboratory.
To get to these certificates, click on Download area on the front page of our website (www.aeschemunex.com). Enter your Login and Password. To print the certificates, it will be necessary for you to enter the code number of the product as well as its batch number.