Quality Standards
Quality Standards
Sterility

Sterility describes the aseptic condition, i.e. the absence of living organism. During the sterilisation process transferable organism such as fungus, bacteria or viruses are elliminated. TPP receives product sterility through a sterile production processes followed by irradiation sterilisation. TPP products are provided sterile only. Sterility is maintained as long as the packaging remains unopened and free from visible defect. Factors such as direct sunlight, moisture and large temperature amplitude changes can have negative effects to the sterility.TPP guaranties a “Sterility Assurance Level” (SAL) of 10-3. The sterility is validated conforming DIN EN ISO 11137.

Expiry-Date
The shelf-life of TPP products is 6 years. Products that are beyond their expiry date (EXP) can cause spurious results or errors. Such products should not be used anymore.
Batch Identification
Each product packaging carries a good visible, black lot number. This batch identification numbers ensures traceability, analyses and monitoring of all data of raw material supply, processes and quality control over a period of several years.
Single Use
All TPP products except accessories such as racks etc. are disposable products and intended for single use only.
CE-Mark / Declaration of Conformity
All products are solely intended for general laboratory use by competent staff. Products for laboratory use cannot be CE-marked. The products have not been registered for their direct use on humans.
Certificate
Quality certificate from TPP can be generated online at www.tpp-india.com/coa by entering the product number and coresponding lot number. For your convenience this service is without the need of registration.
Production
TPP products are manufactured on automatic production lines in a clean room environment, minimising interaction of human contact, thus preventing risk of contamination.
Pyrogens and Endotoxins
Endotoxins belong to the pyrogens, substances that are eliciting fever. They can influence growth and functionality of tissue cultures. For tissue culture, the use of products that are pyrogen-free are recommended only . All TPP products are tested systematically with the LAL test to prove the absence of endotoxins. The Limulus Ameobocyte Lysate assay (LAL) detects minimum amounts of endotoxins by using blood from the Horseshoe Crab, which already shows coagulation in the presence of minimum amounts of endotoxins.The value of endotoxin is <0.06 EU/ml, except for example PCV tubes, tissue culture flask with peel-off foil. Their value is <0.5 EU/ml. Exact data are available from the quality certificates that can be generated at www.tpp-india.com/coa.
RNA / DNA
RNA / DNA are genetic information carriers. Material that is contaminated with RNA / DNA can lead to false positive signals during PCR. They unintentionally amplify along with the desired template. Independent research laboratories periodically test and confirm that no foreign RNA / DNA is detectable with TPP products.
RNase / DNase
RNases / DNases are enzymes that degrade RNA / DNA. They are components of each living cell and cannot be destroyed by the sterilisation process. Independent research laboratories periodically test and confirm that no foreign RNase / DNase are detectable with TPP products.
Growth Treatment
To optimally enhance the adhesion of the cells to the plastic surface, the growth areas of all TPP tissue culture vessels are treated by an optic-mechanic method developed by TPP. The result is a plane and growth enhancing surface that has an optimal proliferation effect. TPP tissue culture products are tested lot wise for their different tissue growth criteria.
Cytotoxic Substances
Cytotoxic substances are cell poisons that have the ability to weaken or even kill cells. All TPP tissue culture products are free from cytotoxic substances. TPP tests this regularly conforming DIN EN ISO 10993-5.
Leaching
Leaching signifies the slow compounds dissolving (leaching) from plastic ware into buffer and solvents. TPP avoids this by using ultrapure raw-material that is certified to be free of chemical softeners and additive. Recycled and by this potential contaminated raw material never is processed with TPP products. All raw material conforms to the medical directives (93/42) and the Pharmacopoeia USP Class VI. In addition during the production optimized moulds that work without any slip agents.