A New Visionon the Media Fill Test

Secured readingAseptic manufacturing is an intricate process for pharmaceutical industries and a risk management plan must be designed to ensure final product safety. Media Fill Test (MFT) is a systematic control that should be included in this plan to build quality in the product and not rely only on final product sterility test.Reading Media Fill units is a real bottleneck and a difficult part of the MFT since it requires highly qualified technicians and much time to manually read up to several thousands of filled units.

Such a manual operation can lead to risks of failed readings, hence the need for improved culture media that can facilitate reading and reinforce the safety for the pharmaceutical industry.

Revolutionary culture media for Media Fill Test (MFT)

Bringing a new dimension to the MFT with a unique colour indicator Easiercontaminationdetection Greatereaseofuse Lessfalsepositiveandfalsenegative

bioMrieux innovates by bringing you a TSB

media for MFT containing a colour indicator(1-2) that will change from pink to yellow if your filled unit is

contaminated.

TSB 3P for MFT

TSEFREE From a regulatory standpoint, the MFT is under strict scrutiny, especially regarding the ingredients from animal origin, like in the European Pharmacopoeia(3): Materials used in the qualification of plant and equipment, such as culture media used in a media fill experiments to validate the aseptic filling process, shall be considered in compliance with this chapter provided that the constituent or constituents are derived from tissues with no detectable infectivity [] When manufacturers have a choice, the use of materials from non TSE-relevant animal species or non-animal origin is preferred.

UNIQUE COLOUR INDICATOR

VALIDATED wITh ThE 3P CRITERIA

OPTIMIzED FOR QUICk

CONTAMINATION DETECTION

COLD-FILTERABLE

OPTIMIzED FOR ANAEROBIC

gROwTh

IRRADIATED 25 kgy

We carry out strict controls of raw materials in our dehydrated culture media manufacturing facility to reach optimal and reliable performances. Upon audits, the full traceability documentation from all the raw materials down to the final product can be accessible for each batch of TSB 3PTM for Media Fill.

OptimizedperformancesBoth TSB 3P Vegetable and Animal Peptones are optimized for the quick detection of aerobic and anaerobic contaminants. 101 wild isolates and pharmacopoeia strains were evaluated amongst which 6 were anaerobic.

SkIN CONTAMINANT Propionebacterium acnes (ATCC 6919) DETECTED IN AS LITTLE AS 4 DAYS AT 20-25C

According to literature, 70% of the pharmaceutical industries consider that personnel contaminants is the most likely source of contamination during Media Fill Tests(4).

(1) STP Pharma Pratiques Vol. 18, n6, On Culture Media Relevance In Aseptic Processes Simulation., November-December 2008

(2) STP Pharma Pratiques Vol. 19, n2, Relevance Of Visual Inspection Before Incubation And Examination Of Aseptic Process Simulation Units., March-April 2009

(3) European Pharmacopoeia, chapter 5.2.8 Minimising The Risk Of Transmitting Animal Spongiform Encephalopathy Agents Via Human And Veterinary Medicinal Products

(4) PDA Technical Report No. 36, Current Practices in the Validation of Aseptic Processing 2001. PDA Journal of Pharmaceutical Science and Technology, May-June 2002; supplement TR36, Vol. 56, Number3

TSE-FREE / BSE-FREEANIMAL-FREE for the vegetable formulation

Fig 1: Growth promotion results on 95 aerobic strains after 7 days at 20-25C. Turbidity values were summed for each micro-organism.

After 7 days at 20-25C, both Vegetal an Animal formulations have a higher turbidity, thus a quicker detection than the control

Fig 2: Proportion of the 6 anaerobic strains that grew after 8 days of incubation at 20-25C on culture media from different suppliers.

After 8 days at 20-25C, for both Vegetal an Animal formulations, 100% of the strains grew, whereas the control and other suppliers had much poorer performances

TESTED FOR ThE ABSENCE

OF VIABLE MYCOPLASMA

OPTIMIzED FOR QUICk

CONTAMINATION DETECTION

TAMPER-PROOFPACkAgINg

OPTIMIzED FOR ANAEROBIC

gROwTh

PhARMACOPOEIA COMPLIANT

FORMULATIONS

PhARMACOPOEIA COMPLIANT

gROwTh PERFORMANCES

bioMrieux S.A.69280 Marcy ltoile - FranceTel. 33 (0) 4 78 87 20 00Fax 33 (0) 4 78 87 20 90www.biomerieux-industry.com

3P CUlTUre Media range For Media Fill TeST

reFerenCe deSCriPTion PaCKaging STorage

51104 TSB 3P irradiated Vegetable peptones + colour indicator 500g dehydrated Room Temperature

51103 TSB 3P irradiated Vegetable peptones + colour indicator

5kg dehydrated

Room Temperature

51102 TSB 3P irradiated Animal peptones 500g dehydrated Room Temperature 51101 TSB 3P irradiated Animal peptones 5kg dehydrated Room Temperature

STeriliTy CUlTUre Media range

reFerenCe deSCriPTion PaCKaging STorage

44011 Trypcase Soy Broth 12 bottles / 100ml Room Temperature

42633 Trypcase Soy Broth

for CLEAN ROOMS 6 bottles / 100ml Room Temperature 44021 Fluid Thioglycolate clear Medium 12 bottles / 100ml Room Temperature 42634 Fluid Thioglycolate clear Medium for CLEAN ROOMS 6 bottles / 100ml

Room Temperature

44001 Fluid Thioglycolate Medium 12 bottles / 100ml Room Temperature 42616 Rinsing Fluid A 4 bottles / 300ml Room Temperature 42624 Rinsing Fluid D 4 bottles / 300ml Room Temperature 42044 Rinsing Fluid A 12 bottles / 100ml Room Temperature

3P CUlTUre Media range For environMenTal MoniToring

reFerenCe deSCriPTion PaCKaging STorage

43691/43699 Count-Tact 3P irradiated 20 / 100 plates Room Temperature

43711/43169 TSA 3P irradiated

4 hours under laminar flow validated

20 / 100 plates

Room Temperature

43811/43819

TSA 3P irradiated with Neutralizers

4 hours under laminar flow validated

20 / 100 plates

Room Temperature

43554* Sabouraud Dextrose 3P irradiated 20 plates Room Temperature

43812* Count-Tact 3P irradiated

Sabouraud Dextrose

20 plates Room Temperature

43814*

Sabouraud Dextrose 3P

irradiated with Neutralizers

20 plates Room Temperature

43801 QUANTISWAB with Transport Tube 200 swabs Room Temperature

* Contact us for local availability

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