Pharmaceutical Quality Control

Millipore offers complete solutions for microbial quality control in the pharmaceutical lab, including test systems, media, rinses, methods development, and validation protocols.

Bioburden

	Method	Devices	Media/Rinses
Incoming raw materials and components In-process samples Finished products	Membrane filtration	Milliflex	Selective and non-selective media Phosphate buffer Fluids A, D, K

Changeover

	Method	Devices
Mammalian cells	Swab	Total Count Swab Test Kit
Fermenter E.coli Yeast	Swab	Coli-Count Swab Test Kit Yeast & Mold Swab Test Kit

Cleaning Validation

	Method	Devices	Media
Surfaces or equipment	Swab	HPC Swab Test Kit
Surfaces or equipment	Rinse	Milliflex Microfil V, Microfil S or filtration funnels	TSA with Poly 80 and lecithin

Environmental Testing

Site	Method	Devices	Media/Rinses
Surfaces Facilities Equipment	Swab	HPC Sampler
Surfaces Facilities Equipment	Rinse	Milliflex Microfil V, Microfil S or filtration funnels	HPC, TSA or SDA with Poly 80 and lecithin Phosphate buffer Fluids A, D, K
Air Cleanrooms or Filling Areas Isolators	Sieve Impaction	M Air T [INSERT PRODUCTLINK]	TSA, Rose Bengal, SDA
Air Cleanrooms or Filling Areas Isolators	Sieve Impaction	M Air T [INSERT PRODUCT LINK]	TSA
Personnel Gloves Gowning	Swab	HPC Sampler
Personnel Gloves Gowning	Rinse	Milliflex Microfil V, Microfil S or filtration funnels	HPC, TSA or SDA with Poly 80 and lecithin Phosphate buffer Fluids A, D, K

Microbial Limits

Sample	Method	Devices	Media/Rinses
Raw materials, in-process goods, finished goods	Membrane filtration	Sterisure	Total aerobic count: TSA, TSA with Poly 80 and lecithin Phosphate buffer Fluids A, D, K
			Total yeast & mold: SDA, SDA with Chloramphenicol, SDA with Poly 80 and lecithin Phosphate buffer Fluids A, D, K
			Indicator organism: TSB in olive jar

Sterility Testing

Sample	Method	Devices	Media/Rinses
Finished goods	MF sterility test	Steritest Sterisure or sterility test funnels	Sterility media Fluids A, D, K

Water (Bioburden) Testing

Sample	Method	Devices	Media
Municipal water, treated water, WFI	Membrane filtration	Milliflex Microfil V, Microfil S MicropreSure or filtration funnels	For total counts: HPC or PCA or R2A For total coliforms: MacConkey or m-Endo LES For presence/absence or identification: Cetrimide (for Ps. aeruginosa) Pseudomonas isolation

Sample

Method

Devices

Media

Municipal water,
treated water,
WFI

Membrane filtration

Milliflex
Microfil V,
Microfil S
MicropreSure
or filtration funnels

For total counts:
HPC or PCA or R2A

For total coliforms:
MacConkey or m-Endo LES

For presence/absence or identification:
Cetrimide (for Ps. aeruginosa)
Pseudomonas isolation

* Millipore recommends the Milliflex System for this application.
For feasibility studies and protocol optimization, check out our Access Methods Development Services.