Products

Bacterial Endotoxins are Lipopolysaccharides (LPS), resulted primarily after desintegration of Gram negative bacteria from their outer cell wall. Endotoxins can cause fever and other biological effects in man and animal even after a small amount of parenteral administration.

Along with sterility testing the detection and quantification of bacterial endotoxin is therefore essential for the release of parenteralia and medical devices.

ACILA® offers a wide range of products such as ACILA® LRW (LAL Reagent Water), PYROKONTROL® Test Tubes and Dilution Tubes, Endotoxins as reference standard as well as bioindicators and further accessory products which can be used in combination with Bacterial Endotoxin Test (BET), such as Limulus Amebocyte Lysate (LAL-) Test or rFC-Test (recombinant Factor C Test).

Our sample vials are available in glass and plastic. They are offered of different volumes. The glass vials are of hydrolytic class I or II.

Sample vials named PYROKONTROL® are aseptic processed. They are free of endotoxins within the detection limit. The plastic bottles are radiation sterilized and reach an S.A.L of 10⁻⁶. The glass bottles are steam sterilized and reach an S.A.L of 10⁻³.

Sample vials named STERICERT® are sterile and endotoxin-free within the detection limit. STERICERT® glass vials contain a defined quantity of aqua ad iniectabilia so that with a validated sterilization procedure in autoclave an S.A.L. of 10⁻⁶ can be guaranteed.

STERICERT® PETG sample vials are dry and individually welded in one shrink foil (STERICERT® 0) or, for transport through various clean room zones and isolators, in one (STERICERT® 1), two (STERICERT® 2) or three (STERICERT® 3) plastic bags. They are finally radiation-sterilized according to a validated procedure. This results in the sterility of the vials and plastic bags from the outermost sterile barrier with an S.A.L. of 10⁻⁶ .

The sub-visible particle content in the vials is less than 10% of the limit values indicated in the European Pharmacopoeia (Ph. Eur.) and United States Pharmacopoeia (USP).

PYROVAC® Sample Vials have been specially developed for the automated preparation of radiopharmaceuticals in corresponding devices from various companies. They can also serve as containers for drugs or diagnostics.

The vials are clear glass bottles made of tubular glass according to DIN EN ISO8362-1 (10ml, 20ml and 25ml) or of molded glass according to DIN EN ISO8362-4 (30ml, 50ml and 100ml), of hydrolytic class I (borosilicate glass), with attached rubber stopper Type I, (multiple piercing possible), closed with a flip-top crimp cap provided with a plastic cap made of PP. This is removed before use of the vial so that the piercing point of the septum reveals with a diameter of approx. 8 mm.

PYROVAC® Sample Vials are provided with a vacuum (approx. 10 mbar). To ensure proper sterilization, each bottle contains between 100 and 1,000 μL of water for injections, depending on its size. The sample vials are sterile inside with an S.A.L of 10-6 and free of detectable endotoxin (endotoxin content < 0.01 I.U. / vial). They are free of visible particles. Sub-visible particle contamination is less than 10% of the limits specified in the European Pharmacopoeia (EP) and the US Pharmacopoeia (USP).

ACILA® offers products and services outside of the standard program as well. Be it only small changes to our existing standard products, customized products and tests or new products that can be included in our product portfolio and services; our flexible team will be happy to help you.

ACILA® offers various animal blood products, mainly of sheep blood. The blood is aseptically collected by puncture of veterinary controlled living animals and aseptically processed. It is either gently defibrinated or treated by an anticoagulant like Heparin, Sodium Citrate, EDTA or Alsever’s Solution. The blood is free of preservatives and antibiotics. It may be used for the simulation of contamination of, for instance, surgical instruments, endoscopes or for testing of disinfectants, as well as an additive for culture media and as raw material for the extraction of erythrocytes.