ultrapure water

Quality control

Water is one of the most important reagents for the production of culture media, as it represents approximately 90% of the composition of the medium.

It is classified in water type 1, type 2 and type 3

According to the specifications of the “National Committee for Clinical Laboratory Standards”, water type 1 is the water with the best quality, and should present ‹1.0 CFU / mL of Bacteria, pH neutral, conductivity 0.055 Micro Siemens / cm, 18.2 M’Ω / cm resistivity, ‹1 particles smaller than 0.02 μm and TOC between 5 to 10 ppb.

LGC Biotecnologia uses a double-step reverse osmosis system to obtain WFI (Water For Injection). The first stage of the equipment works as a pre-treatment, reducing the content of ionic contaminants, particulates, bacteria and organic compounds, leaving the polishing and framing function within the pharmacopoeial limits for the second step.

The Osmosis double-step system dispenses with the need for a previous pre-treatment step (deionization), making it even easier to control process variables and consistency in the quality of the WFI produced.

The conditions of the environment are also extremely important for the proper preparation of the media. This includes daily cleaning and disinfection of the clean area, filling of products in a laminar flow cabinet with HEPA filters and UV system to ensure sterility, microbiological monitoring and particle counting through the classification of rooms participating in an annual validation program.

All equipment used in the manufacture of the media is validated every six months (phmentros, scales, thermometers, greenhouses, pipettes, etc.).

Media processing is performed using Bio Process Containers (BPCs) – Hynetics, using all disposable material.

Before the batches are released, all culture media are subjected to sterility, productivity, inhibitory and indicator tests. Using strains from the American cell bank ATCC * and according to the CLSI (Clinical and Laboratory Standards Institute) – Anvisa the duly qualified technical team performs the validation of the means.

In the manufacture of cell culture media, it is necessary to define the validity, stability monitoring and storage of retention samples (minimum 01 year.)

Other parameters are checked for media validation: Aspect (pink powder), Texture (homogeneous), Particle Size (app. 20 microns), Solubility (clear solution at -1x usage concentration), pH 8.0 + 0, 5 (at 25 ° C – without NaHCO3), pH 8.1 + 0.5 (at 25 ° C – with NaHCO3), Osmolarity * 246 mOsm / Kg H2O + 5% (without NaHCO3) and Osmolarity 290 mOsm / Kg H2O + 5% (with NaHCO3).

For the microbiological control of the culture media, Sabourad Glycosylated medium is used for the detection of yeasts, the Thioglycolate Broth for the detection of endotoxins and the molecular technique by Real Time PCR for the detection of Mycoplasma spp.

LGC Biotecnologia has been registered with ANVISA since 2008, guaranteeing the quality of products and contributing to the advancement of the Brazilian industry.

ATCC is a private center, located in Manassas, Virginia (USA), whose mission focuses on the acquisition, authentication, production, preservation, development and distribution of standard reference microorganisms, cell lines and other materials for life science research .

Osmolarity is the measure of the osmotic pressure of a solution (COMPLETE CULTURE MEDIA). The osmolarity of the culture medium must be simulated to the osmolarity of the cell’s natural environment “in vivo”.

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