Acila Product Catalogue

WATER and BUFFERS

ACILA®LRW (LAL Reagent Water)

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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Glass container

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

Plastic container

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

Buffers

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

TrisSol® Tris-Buffer

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

PYROKONTROL® Phosphate buffer

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

PYROKONTROL® LAL hydrochloric acid, LAL sodium hydroxide, potassium hydroxide

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

PYROKONTROL® isotonic sodium chloride solution (NaCl 0.9 %)

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

ENDOTOXINS (lipopolysaccharides)

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.

REFERENCE STANDARD ENDOTOXIN (RSE)

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 ENDOTOXIN (CSE)

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

ENDOTOXINS as BIOINDICATORS for PROOF of DEPYROGENATION or for the VALIDATION of ULTRAFILTRATION

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

TEST TUBES AND DILUTION TUBES

TEST TUBES

PYROKONTROL® TEST TUBES, soda lime glass

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, borosilicate glass

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

DILUTION TUBES

PYROKONTROL® DILUTION TUBES, borosilicate glass

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

Sampling vials and PHARMACEUTICAL PRIMARY PACKAGING MATERIAL

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® sample vials

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® sample vials

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

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

LIQUID HANDLING

PYROKONTROL® glass pipettes, borosilicate glass

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

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 l (YELLOW) 5 x 96 1440100
50 x 96 1440105
50 - 1,000 l (BLUE) 5 x 96 1440500
50 x 96 1440505
500 - 2,500 l (RED) 5 x 48 1441000
25 x 48 1441005

PYROKONTROL® Combitips Plus

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

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

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

PARAFILM

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

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

Packaging

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

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