| 1. |
WATER and BUFFERS |
 |
| 1.1 |
ACILA® LRW
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. All listed buffers and solutions are free of
endotoxin, as no endotoxin can be detected using the kinetic turbidimetric
method. Other solutions on demand.
|
| 1.2 |
TrisSol® Tris-Buffer
|
| 1.3 |
PYROKONTROL® LAL hydrochloric acid, LAL sodium hydroxide and potassium hydroxide
|
| 1.4 |
PYROKONTROL® Phosphate buffer,
endotoxin content < 0.01 I.U./ml, sterile
|
| 1.5 |
PYROKONTROL® isotonic sodium chloride solution (NaCl 0.9 %),
sterile and free of endotoxin.
|
|
|
| 2. |
ENDOTOXINS (lipopolysaccharides)
|
|
| 2.1 |
REFERENCE STANDARD ENDOTOXIN (RSE)
|
| 2.2 |
CONTROL STANDARD ENDOTOXINS (CSEs)
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| 2.3 |
ENDOTOXINS as BIOINDICATORS (VALIDATION: Depyrogenisation & ultrafiltration)
|
| 2.4 |
BIOINDICATORS and other ENDOTOXINS
|
| 2.5 |
LIPOPOLYSACCHARIDES and their DERIVATIVES for IMMUNOLOGICAL
RESEARCH |
|
|
| 3. |
TEST TUBES AND DILUTION TUBES
|
|
| 3.1 |
PYROKONTROL®TUBES, soda lime
glass
PYROKONTROL®
test tubes from soda lime glass are free of endotoxin (endotoxin content
< 0.03 I.U./ml) and especially suitable as test tubes for the LAL test
(gel-clot method: USP, EP et al.).
Inhibition of the gel-clot
test can be excluded. Endotoxin recovery is positive at 2l.
|
| 3.2 |
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, EP etc.).
Inhibition and enhancement of
the LAL test can be excluded. Endotoxin recovery is ± 50 %.
|
| 3.3 |
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 ± 50 %. They may be re-used after depyrogenation. |
|
|
| 4. |
ACILA® 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 material have likewise different volumes.
All vials named STERICERT® have a SAL 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 SAL of 10-6 can be guaranteed. The
plastic vials are radiation-sterilized with 25 kGy in validated procedure.
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.
The glass vials do not contain
water. Therefore a SAL of 10-6 cannot be guaranteed.
|
|
4.1 |
PYROKONTROL® Glass Sampling Vials (DIN injection vials)
|
|
| 4.2 |
PYROKONTROL® Glass Sampling Vials (DIN infusion vials) |
| 4.3 |
PYROKONTROL® PETG Sampling Vials. |
| 4.4 |
STERICERT®
PETG Sampling vials. |
| 4.5 |
STERICERT® Glass Sampling Vials. |
|
4.6 |
PYROVAC® Sampling 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 <10mbar. To guarantee proper sterilization each vial contains between 100
and 3000 µl water for injection, depending on the vial size. |
|
| 4.7 |
PE Sampling Bottles |
|
|
| 5. |
LIQUID HANDLING
|
|
| 5.1 |
PYROKONTROL® Glass Pipettes, borosilicate glass |
| 5.2 |
PYROTIPS® Pipette tips |
| 5.3 |
PYROKONTROL® Combitips
plus |
| 5.4 |
PYROKONTROL® Reagent Reservoir |
| 5.5 |
PYROKONTROL® Microplate |
|
|
| 6. |
ANIMAL BLOOD,
SERA and PLASMAS
currently in revision
|
|
|
|
| 7. |
MICROBIOLOGY and HYGIENE
|
| 7.1 |
Dried media
- Agar media, finished products
- Broth dried media, ready-to-use
- Basic substances
-
Supplements
|
| 7.2 |
Coloured solutions
- GRAM’S STAIN
- PREPARATION of FUNGI with LACTOPHENOL BLUE
- STAINING of SPORES according to BARTHOLOMEM & MITTWER
|
| 7.3 |
Reagents and material for microbiological laboratories |
| 7.4 |
Accessories |