Sterility Testing of Pharmaceutical Products
Fluid A is a wash solution for sterility testing of aqueous solutions or water-soluble pharmaceutical products using the membrane filtration method.
The formulation is based on the recommendations of the actual European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
Fluid A is available in volumns of 100 ml (125 ml bottle with septum and flip cap, Ref. No. 579100d) and 300 ml (500 ml bottle with septum and flip cap, 300 ml filling volume, Ref. No. 579300d).
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 300 ml
Container: Bottle
Dimensions: 300 ml (Gesamtvolumen)
Closure: Flip cap/septum (d)
579100d Fluid A
Fluid A is a wash solution for sterility testing of aqueous solutions or water-soluble pharmaceutical products using the membrane filtration method.
The formulation is based on the recommendations of the actual European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
Fluid A is available in volumns of 100 ml (125 ml bottle with septum and flip cap, Ref. No. 579100d) and 300 ml (500 ml bottle with septum and flip cap, 300 ml filling volume, Ref. No. 579300d).
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 100 ml
Container: Bottle
Dimensions: 125 ml total volume
Closure: Flip cap/septum (d)
577100d Fluid D
According to USP Fluid D is a suitable washing solution for sterility testing of pharmaceutical products containing lecithin or oil.
The formulation is based on the recommendations of the actual United States Pharmacopoeia (USP).
Fluid D is available in volumns of 100 ml (Ref. No. 577100d, 125 ml bottle with septum and flip cap) and 300 ml (Ref. No. 577300d, 500 ml bottle with septum and flip cap).
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 100 ml
Container: Bottle
Dimensions: 125 ml total volume
Closure: Flip cap/septum (d)
577300d Fluid D
According to USP Fluid D is a suitable washing solution for sterility testing of pharmaceutical products containing lecithin or oil.
The formulation is based on the recommendations of the actual United States Pharmacopoeia (USP).
Fluid D is available in volumns of 100 ml (Ref. No. 577100d, 125 ml bottle with septum and flip cap) and 300 ml (Ref. No. 577300d, 500 ml bottle with septum and flip cap).
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 300 ml
Container: Bottle
Dimensions: 300 ml (Gesamtvolumen)
Closure: Flip cap/septum (d)
510100d Fluid Thioglycollate-Medium (acc. to EP/USP)
Fluid Thioglycollate Medium is an all-purpose complex medium for the cultivation and isolation of fastidious anaerobic microorganisms and also for aerobic microorganisms.
The medium is used for sterility testing of substances, preparations or products according to the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
Fluid Thioglycollate Medium is prepared according to the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
heipha Fluid Thioglycollate Media:
* Thioglycollate Broth EP+USP – 9 ml (Ref. No. 2171r)
* Thioglycollate Broth EP+USP – 10 ml (Ref. No. 2170r)
* Thioglycollate Broth EP+USP – 100 ml (Ref. No. 510100d, 100 ml-bottle with septum/flip cap, filling volume 100 ml)
* Thioglycollate Broth EP+USP – 100 ml (Ref. No. 510100sd, 125 ml-bottle with combined septum and screw cap, filling volume 100 ml)
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 100 ml
Container: Bottle
Dimensions: 125 ml total volume
Closure: Flip cap/septum (d)
510100sd Fluid Thioglycollate-Medium (acc. to EP/USP)
Fluid Thioglycollate Medium is an all-purpose complex medium for the cultivation and isolation of fastidious anaerobic microorganisms and also for aerobic microorganisms.
The medium is used for sterility testing of substances, preparations or products according to the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
Fluid Thioglycollate Medium is prepared according to the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
heipha Fluid Thioglycollate Media:
* Thioglycollate Broth EP+USP – 9 ml (Ref. No. 2171r)
* Thioglycollate Broth EP+USP – 10 ml (Ref. No. 2170r)
* Thioglycollate Broth EP+USP – 100 ml (Ref. No. 510100d, 100 ml-bottle with septum/flip cap, filling volume 100 ml)
* Thioglycollate Broth EP+USP – 100 ml (Ref. No. 510100sd, 125 ml-bottle with combined septum and screw cap, filling volume 100 ml)
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 100 ml
Container: Bottle
Dimensions: 125 ml total volume
Closure: Screw cap with septum (sd)
lct-20 LACTAMATOR
For the inactivation of beta-Lactam-antibiotics.
The Lactamator contains lyophilized Cephalosporinase (>2 kIU) and Penicillinase (>20 kIU).
Storage: 2-8°C
Shelf Life (Months): 12
lct-5 LACTAMATOR
For the inactivation of beta-Lactam-antibiotics.
The LACTAMATORTM contains lyophilized Cephalosporinase (>50 IU) and Penicillinase (>500 IU).
Storage: 2-8°C
Shelf Life (Months): 12
LCT-LQS10 LACTAMATOR
LACTAMATORTM (CPC Biotech SRL, Italy) is a liquid, sterile mixture of a new developed Cephalosporinase and a Penicillinase. The product is suitable for inactivation of lactam antibiotics (penicillins, cephalosporines and carbapenems), e.g. in sterility tests and bioburden tests. Furthermore it can be supplemented to media fills performed in filling lines of -lactam antibiotics.
For the environmental monitoring in production areas of -lactam antibiotics ready prepared culture media with LACTAMATORTM are available:
* TSA Contact + LT + Cephase – ICR+ (Ref. No. 823)
* TSA + LT + Cephase – ICR (Ref. No. 03085e)
Storage: 2-8°C
Shelf Life (Months): 10
Filling volume: 10 ml
514300d NaCl-Peptone-Buffer pH 7.0 (acc. to EP/USP)
Buffered NaCl-Peptone Solution is used for the microbial examination of non-sterile pharmaceutical products, e.g. as solution for sample preparation or as dilution or wash solution.
The formulation is based on the recommendations of the actual European Pharmacopoeia (EP) .
heipha Buffered NaCl-Peptone Solution acc. EP
* Ref. No. 514090
(125 ml bottle with screw cap, 90 ml filling volume)
* Ref. No. 514090-B
(250 ml bottle with screw cap, 90 ml filling volume)
* Ref. No. 514100
(125 ml bottle with screw cap, 100 ml filling volume)
* Ref. No. 514300d
(500 ml bottle with septum and flip cap, 300 ml filling volume)
* Ref. No. 5141000
(1000 ml bottle with screw cap, 1000 ml filling volume)
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 300 ml
Container: Bottle
Dimensions: 300 ml (Gesamtvolumen)
Closure: Flip cap/septum (d)
490100sd Thioglycollate Medium CLEAR
Fluid Thioglycollate Medium Clear is an all-purpose complex medium for the cultivation and isolation of fastidious anaerobic microorganisms but also for aerobic microorganisms.
The medium can be used for validated sterility testing of substances, preparations or products according to European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
In contrast to the Fluid Thioglycollate Medium acc. EP/USP in Thioglycollate Broth Clear the agar is partly replaced by an alternative gelling agent.
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 100 ml
Container: Bottle
Dimensions: 125 ml total volume
Closure: Screw cap with septum (sd)
2171r Thioglycollate-Medium (9 ml) acc. to EP/USP
Fluid Thioglycollate Medium is an all-purpose complex medium for the cultivation and isolation of fastidious anaerobic microorganisms and also for aerobic microorganisms.
The medium is used for sterility testing of substances, preparations or products according to the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
Fluid Thioglycollate Medium is prepared according to the European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
heipha Fluid Thioglycollate Media:
* Thioglycollate Broth EP+USP – 9 ml (Ref. No. 2171r)
* Thioglycollate Broth EP+USP – 10 ml (Ref. No. 2170r)
* Thioglycollate Broth EP+USP – 100 ml (Ref. No. 510100d, 100 ml-bottle with septum/flip cap, filling volume 100 ml)
* Thioglycollate Broth EP+USP – 100 ml (Ref. No. 510100sd, 125 ml-bottle with combined septum and screw cap, filling volume 100 ml)
Storage: 2-25°C
Shelf Life (Months): 6
Filling volume: 9 ml
Container: Tube
Dimensions: Glass 17 ml total volume
490100d Thioglycollate-Medium CLEAR
Fluid Thioglycollate Medium Clear is an all-purpose complex medium for the cultivation and isolation of fastidious anaerobic micro organisms but also for aerobic microorganisms.
The medium can be used for validated sterility testing of substances, preparations or products according to European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
In contrast to the Fluid Thioglycollate Medium acc. EP/USP in Thioglycollate Broth Clear the agar is partly replaced by an alternative gelling agent.
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 100 ml
Container: Bottle
Dimensions: 125 ml total volume
Closure: Flip cap/septum (d)
502100d Tryptic Soy Broth (acc. to EP/USP)
Fluid Tryptic Soy Broth is an all-purpose complex medium for the cultivation and isolation of fastidious aerobic bacteria, yeast and molds.
The medium is used for sterility testing of substances, preparations and products as well as pre-enrichment broth for the test for specified microorganisms or total viable aerobic count determinations using the MPN method within non-sterile products according to European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
Tryptic Soy Broth is prepared according to the European Pharmacopoeia (EP, Broth Medium A) and the United States Pharmacopoeia (USP, Soybean-Casein Digest Medium).
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 100 ml
Container: Bottle
Dimensions: 125 ml total volume
Closure: Flip cap/septum (d)
502100sd Tryptic Soy Broth (acc. to EP/USP)
Fluid Tryptic Soy Broth is an all-purpose complex medium for the cultivation and isolation of fastidious aerobic bacteria, yeast and molds.
The medium is used for sterility testing of substances, preparations and products as well as pre-enrichment broth for the test for specified microorganisms or total viable aerobic count determinations using the MPN method within non-sterile products according to European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
Tryptic Soy Broth is prepared according to the European Pharmacopoeia (EP, Broth Medium A) and the United States Pharmacopoeia (USP, Soybean-Casein Digest Medium).
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 100 ml
Container: Bottle
Dimensions: 125 ml total volume
Closure: Screw cap with septum (sd)
502100-B Tryptic Soy Broth (EP/USP)
Fluid Tryptic Soy Broth is an all-purpose complex medium for the cultivation and isolation of fastidious aerobic bacteria, yeast and molds.
The medium is used for sterility testing of substances, preparations and products as well as pre-enrichment broth for the test for specified microorganisms or total viable aerobic count determinations using the MPN method within non-sterile products according to European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
Tryptic Soy Broth is prepared according to the European Pharmacopoeia (EP, Broth Medium A) and the United States Pharmacopoeia (USP, Soybean-Casein Digest Medium).
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 100 ml
Container: Bottle
Dimensions: 250 ml total volume
Closure: Screw Cap
3080r Tryptic Soy Broth 9 ml
Fluid Tryptic Soy Broth is an all-purpose complex medium for the cultivation and isolation of fastidious aerobic bacteria, yeast and molds.
The medium is used for sterility testing of substances, preparations and products as well as pre-enrichment broth for the test for specified microorganisms or total viable aerobic count determinations using the MPN method within non-sterile products according to European Pharmacopoeia (EP) and the United States Pharmacopoeia (USP).
Tryptic Soy Broth is prepared according to the European Pharmacopoeia (EP, Broth Medium A) and the United States Pharmacopoeia (USP, Soybean-Casein Digest Medium).
Storage: 2-25°C
Shelf Life (Months): 12
Filling volume: 9 ml
Container: Tube
Dimensions: Glass 17 ml total volume
For more information please visit heipha Dr. Muller GmbH Sterility Testing of Pharmaceutical Products.
