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Filtration of Active Pharmaceutical Ingredients (API’s)

3M offers a range of innovative solutions to meet your filtration and purification needs in the Pharmaceutical Manufacturing Industry. Our extensive range of products provide solutions to the most routine of applications through to the more complex situations where our innovation and technology platforms allow us help you be more successful in your production. API

Ease of use, containment, single use, scalability and total cost of ownership are key areas that we address during the development of our solutions.

Our expertise can help you become more efficient in the following key areas:

  • Tank Farm (Solvent) Filtration
  • Tank Venting filtration
  • Water Pre-filtration
  • Catalyst Recovery
  • Decolourisation
  • Particulate Removal
  • Final Pre and Sterile Filtration.

3M Purification understands the needs of the Pharmaceutical Industry and has developed an extensive range of filter technologies that provide solutions to the varied and often most demanding applications encountered. The manufacture of small molecules and API’s often involve filtration of aggressive chemicals at elevated temperatures. 3M therefore embraces its extensive technologies to deliver products with the optimum chemical and thermal compatibility.

API Chart

The Pharmaceutical Industry’s regulatory requirements demand high quality and solutions that can be validated therefore 3M’s pharmaceutical grade filters are all supplied with documented evidence to assist you in meeting these regulatory demands. Our scientists are also trained and available to assist in process development, training, troubleshooting and undertaking process specific validation work.

3M Purification is a global company committed to helping all its customers become more successful.

Housings applicable for this solution are : 3M™ CH Housings, 3M™ HC Housings, 3M™ HF Housings, 3M™ WTB and WTC Housings.

Please see below for more information regarding examples of 3M Purification’s solutions for the Pharmaceutical Industry.

Tank Farm (Solvent) Filtration

Gases, typically nitrogen air and carbon-dioxide are used extensively through-out the production of API’s. Applications include, venting of tanks, purging of equipment and propulsion of liquids from tank to tank.

Certain applications only require removal of particulate to prevent the ingress of particulate contamination whilst other more critical duties require the absolute removal of bacteria and other airborne organisms.

The absolute-rated 3M™ Betafine™ XL filter cartridges feature the novel Advanced Pleat Technology (APT), which increases the usable filtration surface area within the cartridge. 3M™ Betafine™ XL series filters are perfect for removing solid particulate from gases offering reduced system sizing, extended filter service life and broad chemical compatibility.

filters contain a hydrophobic PTFE Membrane which offers exceptional chemical compatibility. Their high filter surface area deliver exceptionally high flow rates whilst maintaining low differential pressures.

The 3M™ LifeASSURE™ PFS series are perfect for assuring sterile filtration of gases, solvents and liquids. They are available in cartridge, mini cartridge and capsule formats.

Solvent Filtration

The production of API’s involve many varied liquid filtration applications.

Starting at the Tank Farm there will be a need for course “Trap” filtration through which bulk deliveries will be filtered to prevent the ingress of solid particulate into the bulk storage tanks.

Moving down the process and into the reaction stages there will be need for finer levels of filtration up to and including full sterile filtration. 3M’s product ranges covers all the usual formats from bags – tubular, lenticular and sheet depth filters through to pleated tubular constructions.

3M™ NB Series are provided in a range of formats, materials and grades that make an excellent choice for retrofitting into existing Tank Farm Applications.

Cleanable stainless steel metal filter cartridges are specially designed to treat fluids with a high viscosity, high temperature, high purity and corrosive properties.

3M™ Micro-Klean™ D filter cartridges. These cartridges are suitable to use for aggressive solvent filtration thanks to the excellent compatibility of the cotton media and the 316 stainless steel core.

More critical applications requiring higher levels of purity can be addressed with 3M™ Betafine™ XL. The absolute-rated 3M™ Betafine™ XL filter cartridges feature a pleated design called Advanced Pleat Technology (APT), which increases the usable filtration surface area and also dramatically enhances service life. As a result fewer cartridges are needed, the production downtime is lower and thus the overall costs are reduced.

3M™ Betapure™ NT-P combine depth filter structure in a unique format that enables an increased flow rate and a longer cartridge service life. Their all polypropylene construction offers 3M™ Betapure™ NT-P is the ideal solution for batch pre-filtration where higher levels of contamination may be expected.

The 3M™ Zeta Plus™ SP are lenticular depth filters constructed from cellulose and filter aids designed to retain contaminants through mechanical filtration and electrokinetic adsorption. The 3M™ Zeta Plus™ SP series is especially intended for pharmaceutical applications such as solvent and reaction medium filtration. In addition to conventional filtration their flat surface provides excellent performance in recovering high volumes of solids such as activated carbon, expressed salts and catalyst recovery. Their inert materials of construction provide a filter with excellent chemical compatibility.

Water Pre-filtration

Pharmaceutical Plants can be large users of water, all of which needs to be purified for many different applications.

3M™ 740B cartridge series is the best solution for high flowing pre-filtration in water supply systems. The 3M™ 740B series benefits from its patented 3M radial pleating technique to ensure a particularly large and effective filtration surface area.

Catalyst recovery

Modern API Processes are making increased use of Metal Catalysts which need to be recovered after use. Recovery can take two forms – the first been the removal of solids whilst the second is scavenging of dissolved catalysts salts to meet the FDS’s requirements for impurity.

The 3M™ Zeta Plus™ SP Series are lenticular depth filters constructed from cellulose and filter aids designed to retain contaminants through mechanical filtration and electrokinetic adsorption. The 3M™ Zeta Plus™ SP series is especially intended for pharmaceutical applications. Their flat surface provides excellent performance in recovering high volumes of solids such as activated carbon, expressed salts and catalyst. The binder resin used in the media also has the capability of adsorbing dissolved impurities. 3M can customize the formulation of ZetaPlus to immobilize other chemistries such as functionalized silica which can be engineered to remove specific metals compounds from the solution.

The CUNO™ CTG system is a self-contained and ready-to-use system in which the filters are packaged inside a liner pack. This closed system contains tubular filter cartridges (see range above) and the liner pack provides a flexible containment system that can help reduce operator exposure.

Additive and insoluble retention

API Manufacturing requires the removal of additives and insoluble impurities.

The 3M™ NB filter bag series meets these filtration requirements. They offer much capacity to ensure the retention of solid particulate inside the filter bag. They are manufactured with high performance fibre with no adhesives, binders.

The 3M™ Zeta Plus™ SP lenticular filters offer an alternative solution for additive and insoluble retention. When used for the recovery of high solids content their design allows for the capture of solids in the space between the individual cells.

Each cell contains two 3M™ Zeta Plus™ SP media discs sealed with a polypropylene separator intended to improve the flow rate. The internal separator reinforcement and the additional diffuser on each media disc contribute to an optimal use of the filter surface area and remain sealed throughout the complete filtration cycle.

Discolouration – retention of organic compounds

Activated carbon is used extensively in the pharmaceutical industry to remove colour from API solutions prior to crystallisation, lower the levels of dissolved homogeneous catalysts and to retain organic compounds such as pesticides in plant extracts.

Process of immobilised activated carbon in a matrix

Process of immobilised activated carbon in a matrix

3M™ ZetaCarbon is a series of filters that immobilize activated carbon in a rigid cellulose and resin matrix through which the fluid is passed.

Liquids of different viscosity are addressed by having 3 different standard porosities of media and different impurity species can be removed by selecting one of 5 different carbon types. In addition to the catalogue range of products 3M have the ability to customize a formulation specific to your needs by incorporating your specific type of carbon into a product which can greatly reduce the burden of re-validating your process when upgrading from bulk powdered activated carbon (PAC).

3M™ ZetaCarbon delivers many benefits in optimizing your process such as higher efficiency and yields, greater purity, less processing steps whilst producing a safer and cleaner environment for your operators to work in.

Particle pre-filtration of feedstock or final products

The 3M™ Betafine™ XL, 3M™ Betafine™ PPXL and Betafine™ T are high performance solutions for providing cost-effective optimization for particle trap filtration and protection of critical final sterile membrane filtration.

3M™ Betafine™ XL and 3M™ Betafine™ filter cartridges are all polypropylene filter cartridges with high surface areas that dramatically reduce differential pressures thus increasing service life. Higher surface areas can also offer smaller solutions to reduce the overall costs of ownership.

3M™ Betafine™ T cartridges employ pleated cellulose filter media which can give improved chemical compatibility for extreme service conditions. These filters are perfect for delivering high retention and removal efficiencies when employed as a trap filter for removing carbon fines.

3M™ LifeASSURE™ PLA or 3M™ LifeASSURE™ PNA series filters are perfect for pre-filtration for final sterile filtration or for final filtration when the drug substance is to be terminally sterilized by autoclave etc.

3M™ LifeASSURE™ PLA contain a novel graded density Nylon N6.6 Membrane whilst 3M™ LifeASSURE™ PNA contain a PES Membrane. Both products are available in all the standard industry formats for capsules and cartridges.

To discuss any of these applications or your specific requirements with one of our trained technicians contact us