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Is distilled water and may be used as EP1 or USP2 LAL water for all methods of LAL testing. Its specification is listed below
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| vials/pack | ml/bottle | REF |
|---|---|---|
| 10 | 30ml | 1715004 |
| 100 | 30ml | 1715014 |
| 10 | 50ml | 1715006 |
| 100 | 50ml | 1715007 |
| 10 | 100ml | 1715015 |
| 50 | 100ml | 1715020 |
| 6 | 500ml | 1715054 |
| 6 | 1000ml | 1715105 |
| Vials/pack | ml/bottle | REF |
|---|---|---|
| 10 | 60 ml | 1716-0060 |
| 200 | 60 ml | 1716-0060 |
| 96 | 100 ml | 1716-0100 |
| 10 | 125 ml | 1716-0125 |
| 96 | 125 ml | 1716-0125 |
| 6 | 500 ml | 1716-0600 |
| 6 | 1000 ml | 1716-1000 |
All listed buffers and solutions are free of endotoxin, as no endotoxin can be detected using the bacterial Endotoxins Test (EP 2.6.14 and USP <85>. Other solutions on demand
| Product | Specification |
|---|---|
| Endotoxin | < 0.01 I.U./ml |
| sterilisation method | steam sterilisation 121 °C to 124 °C, >15 min |
| pH-value | ± 0,1 |
| packaging | bottle for injections, glass type I |
Endotoxin free Tris buffer are especially suitable for LAL tests lysates. The lysate can be dissolved in
Tris buffer instead of water (observing the specifications of the lysate manufacturer).
Thereby the buffer without colour is used for dissolving lysates when the kinetic turbidimetric method
is used; the buffer with colour is used for the reconstitution of lysates, when the gel clot method is
chosen. This way pH adjustment of the test product can often be avoided, and for some products a special
sample preparation is not necessary
| Product | ml/bottle | bottles/pack | Ref |
|---|---|---|---|
| TrisSol, 0.05 M - pH 7.4 at 37oC | 50 ml | 1 | 1715200 |
| TrisSol, 0.1 M - pH 7.4 at 37oC | 50 ml | 1 | 1715215 |
| TrisSol, 0.15 M - pH 7.4 at 37oC | 50 ml | 1 | 1715240 |
| TrisSol, 0.2 M, red - pH 7.4 at 37oC | 5.5 ml | Oct-80 | 1715265 |
| TrisSol, 0.2 M - pH 7.4 at 37oC | 5.5 ml | Oct-80 | 1715250 |
| 5.5 ml | 1 | 1715255 |
| Product | ml/bottle | bottles/pack | Ref. |
|---|---|---|---|
| 0.1 M Phosphate buffer pH 6.0 | 100 ml | 10 | 1712410 |
| 1/15 M Phosphate buffer pH 6,8 (Sörensen) | 100 ml | 10 | 1712411 |
| 0.1 M Phosphate buffer pH 7.0 | 100 ml | 10 | 1712420 |
| 0,1 M Potassium phosphate buffer pH 7,0 | 100 ml | 10 | 1712430 |
The listed products correspond to the specification of EP1 and USP2 They contain no detectable endotoxin
| Product | ml/bottle | bottles/pack | Ref |
|---|---|---|---|
| 0.1 N LAL-Hydrochloric acid | 100 | 1 | 1712300 |
| 1.0 N LAL-Hydrochloric acid | 100 | 1 | 1712310 |
| 0.1 N LAL-Sodium hydroxide | 100 | 1 | 1712200 |
| 1.0 N LAL-Sodium hydroxide | 100 | 1 | 1712210 |
| 0.1 N LAL-Potassium hydroxide | 100 | 1 | 1712220 |
| 1.0 N LAL-Potassium hydroxide | 100 | 1 | 1712225 |
| Product | ml/bottle | bottles/pack | Ref. |
|---|---|---|---|
| NaCl 0,9% sterile, endotoxin content <0.01 I.U./ml | 100 ml | 10 | 1715165 |
| 100 ml | 50 | 1715170 | |
| 500 m | 6 | 1715175 | |
| 1000 ml | 6 | 1755180 |
ACILA Dr. Weidner GmbH offers endotoxins (lipopolysaccharides or LPSs) for various applications, including the Limulus-Amebocyte-Lysate testing (LAL test) and the Pyrogen tests. They can also be used as bioindicators as required for the validation of depyrogenation processes or ultrafiltration.
Endotoxins from different species of bacteria obviously contain different amounts of lipid A. Our endotoxins are prepared according to the WESTPHAL method and highly purified. Opposite to most endotoxin preparations, those of ACILA do not contains any fillers.
The different Pharmacopoeias (Europe, USA, Japan), the World Health Organisation (WHO) and the Food and Drug Administration (FDA) differentiate a Reference Standard Endotoxin (RSE) from a Control Standard Endotoxin (CSE).
For reference, endotoxin units were defined to have identical activities, when the Limulus Amebocyte Lysate test (LAL test) was harmonized as far as the three main Pharmacopoeias were concerned in 1997: United States Pharmacopoeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP).
1 I.U. (International Unit and EP Unit) = 1 E.U. (Endotoxin Unit, FDA) = 1 USP Unit These RSE’s, however, are still found with different product names and with their individual units depending on their origin.
| LPS | Product name | Institution of origin | Units |
|---|---|---|---|
| E. coli O113 | 2 nd Int. Standard | WHO | 10,000 I.U./vial |
| E. coli O113 | BRP current lot | European Pharmacopoeia | 10,000 I.U./vial |
| E. coli O113 | USP current lot | USP | 10,000 I.U./vial |
| E. coli O113 | EC current lot | FDA | 10,000 I.U./vial |
The International Standard of the WHO and the EC current lot of the FDA are available only for certain reference laboratories or producers of Limulus lysate.
The other RSE’s (the European BRP and the USP current lot) may be purchased either at the office of the respective Pharmacopoeias or from ACILA Dr. Weidner GmbH.
REFERENCE STANDARD ENDOTOXINS (lyophilized with fillers)
| Product name | Institution of origin | Price | Article No |
|---|---|---|---|
| Lot G4 | USP | on request | 1220200 |
| BRP 5 | European Pharmacopoeia | on request | 1220211 |
Control Standard Endotoxins (CSE) are working standards with individual activities depending on the lot of lysate and the method of LAL testing used. Therefore, the activity of a given CSE must be compared to a RSE prior to routine testing. Most producers of LAL provide certificates for their individual lysate lots as far as determined with a given CSE.
| Product name | LPS | Amount | Price | Article No |
|---|---|---|---|---|
| NP4 (liquid) | S. abortus equi | Vial with 1.1 ml and 100 ng/ml | on request | 1220302 |
| LPS E.coli O55:B5 | E.coli O55:B5 | Vial with 10 ng | on request | 1220305 |
The endotoxins listed below were produced without additives to increase their heat resistance. If products have been lyophilised, vials may seem to be empty due to their low contents of LPS. On the other side, many endotoxin preparations contain fillers (e.g. lactose) to increase solubility. These lyophilisates look well filled as the official RSEs.
Lipids of Salmonella abortus equi are sterile aqueous solutions.
We may draw your attention to the particular filling activities of our production team. According to the needs of our clients, ACILA AG fills endotoxins of any concentration into sterile and endotoxin-free vials, ampoules, bottles of various sizes or even syringes to prepare bioindicators for depyrogenation studies. Contact us for more information.
BIOINDICATORS and other ENDOTOXINS
| I.U./Vial Depending on test and lysate | Vials/Box | Price | Product name |
|---|---|---|---|
| LPS E. coli O55:B5, lyophilised 2 mg | > 6,000,000 1 | on request | 1230320 |
| LPS E. coli O55:B5, lyophilised 1 mg x | 3,000,000 1 | on request | 1230315 |
| LPS E. coli O55:B5, lyophilised 10 µg | 100,000 10 | on request | 1230365 |
| LPS E. coli O55:B5, lyophilised 5 µg | 50,000 10 | on request | 1230360 |
| LPS E. coli O55:B5, lyophilised 1 µg | 10,000 10 | on request | 1230355 |
| LPS E. coli O55:B5, lyophilised 0.5 µg | 5,000 10 | on request | 1230350 |
| LPS E. coli O55:B5, lyophilised 0.1 µg | 1,000 10 | on request | 1230335 |
| LPS S. abortus equi, liquid 5mg / 5 ml | 5 mg / 5 ml 1 | on request | 1230010 |
PYROKONTROL® test tubes from soda lime glass are free of endotoxin (endotoxin content < 0.015 I.U./ml) and especially suitable as test tubes for the LAL test (gel-clot method : USP, European Pharmacopoeia et al.). Inhibition of the gel-clot test can be excluded. Endotoxin recovery is positive at 2λ.
| Product | Tubes/Pack | Article No |
|---|---|---|
| PYROKONTROL® tubes 10 x 75 mm with Separate screw cap (from Hostalen, red) | 50 | 1958200 |
| PYROKONTROL® tubes 10 x 75 mm capped (screw cap from Hostalen, red) | 50 | 1958300 |
| PYROKONTROL® tubes 10 x 75 mm capped (screw cap from Hostalen, white) | 50 | 1958330 |
| PYROKONTROL® tubes 10 x 75 mm without screw connection | 50 | 1958400 |
| PYROKONTROL® tubes 12 x 75 mm without screw connection | 50 | 1987500 |
PYROKONTROL® test tubes from borosilicate glass are free of endotoxin (endotoxin content < 0.001 I.U./ml) and especially suitable as test tubes for the LAL test kinetic turbidimetric method or gel-clot method (USP, European Pharmacopoeia & al.).
Inhibition and enhancement of the LAL test can be excluded. Endotoxin recovery is ± 25 %.
| Product | Tubes/Pack | Article No |
|---|---|---|
| PYROKONTROL® tubes 10 x 75 mm capped screw cap from Hostalen, white | 25 | 1958350 |
| 50 | 1958360 | |
| PYROKONTROL® tubes 9.75 x 75 mm, without screw connection, for tube reader LAL-5000 | 50 | 1958600 |
| PYROKONTROL® tubes 7.75 x 75 mm, without screw connection, for tube reader ATI-6000, PYR-032, PYROS KINETIX | 50 | 1959000 |
| 100 | 1959100 |
PYROKONTROL® dilution tubes from borosilicate glass are used for sample preparation for the LAL test. The tubes are free of endotoxin (endotoxin content < 0.001 I.U./ml).
Inhibition and enhancement of the LAL test can be excluded. Endotoxin recovery is ± 25 %. They may be re-used after depyrogenation.
| Product | Tubes/Pack | Article No |
|---|---|---|
| PYROKONTROL® dilution tubes 12 x 75 mm, without screw connection | 50 | 1987600 |
| PYROKONTROL® dilution tubes 13 x 100 mm, without screw connection | 50 | 1958630 |
| PYROKONTROL® dilution tubes 16 x 90 mm, with metal screw cap | 70 | 1958650 |
| PYROKONTROL® dilution tubes 16 x 100 mm, centrifuge tube | 10 | 1958700 |
| PYROKONTROL® dilution tubes 16 x 160 mm, without screw connection | 10 | 1958800 |
| PYROKONTROL® dilution tubes 16 x 100 x 0.8 mm, without screw connection | 10 | 1958705 |
| 16 | 1958710 |
ACILA sample vials are available from glass or plastic. Glasses are offered of different volume and of hydrolytic class I and II. The plastic vials from different materials have likewise different volumes.
Sample vials named PYROKONTROL® are aseptic processed. They are free of endotoxin with a detection limit of < 0.001 I.U. per ml nominal volume. These glass vials do not contain water, therefore a Sterility Assurance Level (S.A.L.) of 10-6 cannot be guaranteed.
All vials named STERICERT® have a S.A.L. of 10-6.
They are free of endotoxin with a detection limit of < 0.001 I.U. per ml nominal volume. STERICERT®® glass vials contain a defined quantity of aqua ad iniectabilia, so that with a validated sterilization procedure a S.A.L. of 10-6 can be guaranteed. STERICERT® plastic vials are radiation-sterilized with 25 kGy in validated procedure.
PYROKONTROL® glass sample vials (DIN injection vials)
PYROKONTROL® glass sample vials (inj.) are clear glass injection vials, DIN hydrolytic class I (10 ml, 20 ml) respectively DIN hydrolytic class II (50 ml, 100 ml), with 20 mm injection flange. They are sealed with a Tefloncoated septum and a flange tear-off cap. The vials are dry, free of endotoxin (endotoxin content < 0.001 I.U./ml) and sterile on the inside. They are delivered with separate labels, in packages of 10 vials. These vials are recommended for uptake and transport of liquid or solid samples for LAL testing. For resealing, the septum has to be flanged with a simple 20 mm flange cap e.g. with the aid of a pair of hand crimping tongs.
| Product | Specification | Vial/Box | Article No |
|---|---|---|---|
| PYROKONTROL glass sample vials | 10 ml | 80 | 1960503 |
| PYROKONTROL glass sample vials | 20 ml | 20 | 1960502 |
| PYROKONTROL glass sample vials | 50 ml | 10 | 1960501 |
| PYROKONTROL glass sample vials | 100 ml | 10 | 1961001 |
PYROKONTROL®_glass sample vials (DIN infusion vials)
PYROKONTROL® glass sample vials (inf.) are clear glass infusion vials (light) DIN hydrolytic class II, with a 32 mm injection flange. They are sealed with a septum and a flange tear-off cap. On the inside, the vials are sterile and moistened with a defined amount of ACILA® LRW. These vials are suitable e.g. for uptake and transport of liquid or solid samples for sterility testing or for counts of bacterial olonies. For resealing, the septum has to be flanged with a simple 32 mm flange cap e.g. with the aid of a pair of hand crimping tongs.
| Product | Specification | Vial/Box | Article No |
|---|---|---|---|
| PYROKONTROL glass sample vials with 0.5 ml ACILA LRW | 100 ml | 10 | 1961010 |
PYROKONTROL® PETG sample vials
PYROKONTROL® PETG sample vials are square vials with a screw cap of HDPE. The vials are firmly closed and individually welded in shrink foil. They are free of endotoxin (endotoxin content < 0.02 I.U./vial) and sterile on the inside. The vials are available in neutral or brown stained plastic.
| Product | Specification | Vial/Box | Article No |
|---|---|---|---|
| PYROKONTROL® PETG sample vials | 30 ml | 280 | 1960118 |
| PYROKONTROL® PETG sample vials | 60 ml | 200 | 1960120 |
| PYROKONTROL® PETG sample vials | 125 ml | 96 | 1960125 |
| PYROKONTROL® PETG sample vials of brown stained | 125 ml | 96 | 1960175 |
| PYROKONTROL® PETG sample vials | 500 ml | 48 | 1960150 |
STERICERT® PETG sample vials
STERICERT® PETG sample vials are square vials with a screw cap from HDPE. The vials are firmly closed and individually welded in shrink foil (STERICERT® 0).
They are free of endotoxin (endotoxin content < 0.02 I.U./vial). The particle content is less than 10% of the limit values indicated in the United States Pharmacopoeia (USP). Sterility is reached by ß-sterilization with 25 kGy, with a S.A.L. of 10-6. The vials are available in neutral or brown stained plastic.
For testing and transport in isolators or clean rooms, the vials can be wrapped in one, two or even three plastic bags.
| Product | Specification |
|---|---|
| STERICERT® 0 | Welded in shrink foil, inside sterile. |
| STERICERT® 1 | Wrapped in a transparent plastic bag ; vial sterile on inside and outside. |
| STERICERT® 2 | Wrapped twice in transparent plastic bags ; vial and first plastic bag sterile ; for clean rooms and isolators. |
| STERICERT® 3 | Wrapped three times in transparent plastic bags ; vial, first and second plastic bag sterile ; for clean rooms and isolators. |
STERICERT® 0
Welded in shrink foil, inside sterile.
| Product | ml/Vial | Vial/Box | Article No° |
|---|---|---|---|
| STERICERT® 0 sample vials | 60 ml | 200 | 1960201 |
| STERICERT® 0 sample vials | 125 ml | 96 | 1960206 |
| STERICERT® 0 sample vials of brown stained | 125 ml | 96 | 1960250 |
| STERICERT® 0 sample vials | 500 ml | 48 | 1960211 |
STERICERT® 1
Wrapped in a transparent plastic bag ; vial sterile on inside and outside.
| Product | ml/Vial | Vial/Box | Article No° |
|---|---|---|---|
| STERICERT® 1 sample vials | 60 ml | 10 | 1960215 |
| STERICERT® 1 sample vials | 125 ml | 10 | 1960220 |
| STERICERT® 1 sample vials of brown stained | 125 ml | 50 | 1960221 |
| STERICERT® 1 sample vials | 500 ml | 5 | 1960225 |
STERICERT® 2
Wrapped twice in transparent plastic bags ; vial and first plastic bag sterile ; for clean rooms and isolators.
| Product | ml/Vial | Vial/Box | Article No° |
|---|---|---|---|
| STERICERT® 2 sample vials | 60 ml | 10 | 1960350 |
| STERICERT® 2 sample vials | 125 ml | 10 | 1960260 |
| STERICERT® 2 sample vials of brown stained | 125 ml | 10 | 1960285 |
| STERICERT® 2 sample vials | 500 ml | 10 | 1960265 |
STERICERT® 3
Wrapped three times in transparent plastic bags ; vial, first and second plastic bag sterile ; for clean rooms and isolators.
| Product | ml/Vial | Vial/Box | Article No° |
|---|---|---|---|
| STERICERT® 3 sample vials | 60 ml | 10 | 1960270 |
| STERICERT® 3 sample vials | 125 ml | 10 | 1960280 |
| STERICERT® 3 sample vials of brown stained | 125 ml | 10 | 1960287 |
| STERICERT® 3 sample vials | 500 ml | 10 | 1960227 |
STERICERT® glass sample vials – Hydrolytic Class I
| Product | ml/Vial | Vial/Box | Article No° |
|---|---|---|---|
| STERICERT® glass sample vials | 30 ml | 10 | 1960300 |
| 100 | 1960301 | ||
| STERICERT® glass sample vials | 30 ml | 10 | 1960305 |
| 50 | 1960306 |
Endotoxin content : < 0.001 I.U./ml
| Product | Volume | Pipettes/Pack | Article No |
|---|---|---|---|
| Glass pipettes | 1 ml | 10 | 1720001 |
| Glass pipettes | 2 ml | 10 | 1720002 |
| Glass pipettes | 5 ml | 10 | 1720005 |
| Glass pipettes | 10 ml | 10 | 1720010 |
PYROTIPS® pipette tips for pipettes of the company eppendorf. In combination with these pipettes, the tips guarantee a maximum of reproducibility of the pipetted volumes. PYROTIPS® pipette tips meet all requirements of DIN 12650-2 as well as of the future EN ISO 8655-2. PYROTIPS® pipettes tips are also compatible with some other pipettes from other manufacturers. The tips are free of endotoxin (endotoxin content: < 0.001 I.U./ml).
The tips are offered in packs of 5 plastic boxes of 48 tips each (= 240 tips, RED) respectively 5 plastic boxes of 96 tips each (= 480 tips, YELLOW, BLUE).
Boxes and tips are autoclavable.
| Specification | Tips/Pack | Article No |
|---|---|---|
| 2 - 200 µl (YELLOW) | 5 x 96 | 1440100 |
| 50 x 96 | 1440105 | |
| 50 - 1,000 µl (BLUE) | 5 x 96 | 1440500 |
| 50 x 96 | 1440505 | |
| 500 - 2,500 µl (RED) | 5 x 48 | 1441000 |
| 25 x 48 | 1441005 |
PYROKONTROL® Combitips Plus are manual dispenser containers for using in combination with eppendorf Multipette Plus.
The Combitips are individually packed in blisters and free of endotoxin (endotoxin content: < 0.001 I.U./ml) and free of Beta (1-3)-Glucan (content: < 3.12 pg/ml). PYROKONTROL® Combitips are available in packs of 100 tips.
| Specification | Tips/Pack | Article No |
|---|---|---|
| 2.5 ml | 100 | 1451100 |
| 5.0 ml | 100 | 1451105 |
PYROKONTROL® reagent reservoirs are containers for reagent with a tapered bottom for taking up the reagent with multi-channel pipettors.
They hold ca. 50 –60 ml of reagent. The reservoirs are free of endotoxin (endotoxin content : < 0.001 I.U./ml) and autoclavable
| Pieces/Pack | Article No |
|---|---|
| 10 | 1450305 |
| 20 x 10 | 1450310 |
PYROKONTROL® microplates have 96 wells with flat bottom.
The surface is untreated. They are sterile and free of endotoxin and Glucans. The microplates are individually wrapped and suitable for LAL tests and determination of Glucans.
| Pieces/Pack | Article No |
|---|---|
| 1 | 1450400 |
| 50 | 1450410 |
Endotoxin content : < 0.01 I.U./cm
| Specification | Article No |
|---|---|
| Parafilm 10 cm (4 In. x 125 Ft.) | 7910125 |
| Parafilm 5 cm (2 In. x 250 Ft.) | 7910130 |
PYROVAC® sample vials with vacuum, sterile, endotoxin-free, are recommended for preparation and storage of radiopharmaceuticals. They serve as containers for drugs or diagnostics that are filled on automatic systems of different companies. For easy filling, the vial is supplied with a vacuum of <_10_mbar. To guarantee proper sterilization, each vial contain between 100 and 3,000 µl water for injection, depending on the vial size.
| Products | Units |
|---|---|
| Sterility Assurance Level | S.A.L. of 10-6 |
| Endotoxin | < 0.001 I.U. per ml volume |
| Particles • Visible • Invisible | none < 10% of USP² or EP¹ specifications |
| Vials or bottles | Norm ISO 8362-1 |
| Glass | Hydrolytic Class I (borosilicate glass Fiolax® from Company Schott) |
| Septum | Bromobutyl lyophilization stoppers (EP¹, USP²) |
| Vacuum | < 10 mbar |
| Water content | 100-3,000 μl aqua ad iniectabilia (water for injection or WFI) |
EP¹ : European Pharmacopoeia
USP² : United States Pharmacopoeia
| ml/Vial | Vials/Box | Article No° |
|---|---|---|
| 10 ml | 80 vial/box | 1960500 |
| 15 ml | 20 vial/box | 1960497 |
| 20 ml | 10 vial/box | 1960495 |
| 25 ml | 20 vial/box | 1960490 |
| 30 ml | 10 vial/box | 1960489 |
| 50 ml | 10 vial/box | 1960492 |
| 100 ml | 10 vial/box | 1960491 |
