Filtration Sterilization Contents + Principle of filtration sterilization + Advantages and limitations of filtration sterilization = Depth and screen filters ‘+ Method of filtration sterilization + Advantages and disadvantages + Types of bacteriological filters « Advantages and disadvantages of each type of filter Learning objectives At the end of this lecture, the student will be able to: + Explain the principle of filtration sterilization + Listtthe advantages and limitations of filtration sterilization + Differentiate between depth filters and screen filters * Describe the mechanism of different classes of filters + Explain the steps involved in filtration sterilization + List different types of bacteriological filters + Explain the advantages and disadvantages of different types of filters ration sterilization + Filtration removes, rather than destroying the microorganisms ‘ Itis capable of preventing the passage of both viable and nonviable particles jids and gasesApplications « Sterilization of heat-sensitive injections, ophthalmic solutions and biological products ‘Filtration of air and other gases for supply to aseptic areas, ‘+ As a part of venting systems on fermentors, centrifuges, autoclaves and freeze driers * Used in sterility testing Mechanism of filtration steri ation * Major mechanisms of filtration are si ng, adsorption and trapping within the matrix of the filter material Types of filtration 1. Surface Filtration: \n surface filtration the medium is used to support the captured solids which deposit onto the medium (called septum, membranes, cloth etc) during operation. Removal of solids is effected by the previously deposited solids or cake. ‘As the cake builds so does the resistance to flow Surface Filtration y Media Particles2. Depth Filtration: In depth filtration the suspended particles enter into the porous medium (called grains) and move to the grain surface for attachment or re-entry into the fluid, repeating this procedure through the filter column Depth Filtration se Fluid Particles et) Types of filters used for sterilization Surface filters Depth filters = The size of particles retained is slightly higher than the mean pore size of medium. = Mechanical strength of filter medium is less, unless it is made of stainless steel. It has low capacity. The size of particles retained is more predictable. = Equipment is expensive because ancillary equipment such as edge clamps is required. u Ex. Cellulose membrane filter. Filtration sterilization of liquids m Mechanical = The size of particles retained is much smaller than the mean pore size of medium. strength of medium is high. It has high capacity. filter = The size of particles retained is less predictable. = Equipment is cheaper because ancillary equipment is not required. mn Ex. Ceramic filters and sintered filters. ‘+ Membrane filters of 0.2 - 0.22mm nominal pore diameter are chiefly used * Sintered filters are used only in restricted circumstances, i.e. for the processing of corrosive liquids, viscous fluids or organic solvents «Filtration sterilization is an aseptic process and careful monitoring of filter integrity is necessary as well as final product sterility testingCotton plug in vacuum line ensures sterility Sterile. ‘Vacuum line filtrate + Filtration under pressure - filling at high flow rates directly into the final containers without problems of foaming, solvent evaporation or air leaks * Membrane filters are often used in combination with a coarse-grade fibreglass depth prefilter to improve their dirt- handling capacity Filtration sterilization * To increase the filtration area, and hence process volumes, several filter discs can be used in parallel in multiple-plate filtration systems * Alternatively, membrane filters can be fabricated into plain or pleated cylinders and installed in cartridgesration sterilization of gases Applications ‘Filtration sterilization of gases is in the provision of sterile airto Aseptic manufacturing suites Hospital isolation units — Operating theatres High Efficiency Particulate Air (HEPA) filters «Filters employed generally consist of pleated sheets of glass microfibers separated and supported by corrugated sheets of Kraft paper or aluminium Acloser look at a HEPA filter ‘+ HEPA filters can remove up to 9.997% of particles >0.3mm in diameter and thus are acting as depth filters * Air is forced through HEPA filters by blower fans, and prefilters are used to remove larger particles to extend the lifetime of the HEPA filterLAMINAR AIR FLOW BENCH CHEMfE? veoxrara jf] —acmucsieer sme. merce Other ications of fil « Sterilization of venting or displacement air in tissue and microbiological culture (carbon filters and hydrophobic membrane filters) * Decontamination of air in mechanical ventilators (glass fibre filters) * Treatment of exhausted air from microbiological safety cabinets (HEPA filters) * Clarification and sterilization of medical gases (glass wool depth filters and hydrophobic membrane filters) ramic filter - dle fil Division Plate Filter head Sludge outietSintered glass and metal filtersAdvantages of filtration sterilization 1. Ideal for thermolabile substances like blood products, insulin and enzymes 2. Useful for large volume solutions 3, Both clarification and filtration achieved 4. Filtered organisms can be further cultured 5. All bacteria, living and dead are removed 6, Rapid supply of small volume parenteral in emergency 1. Sterility testing required 2. Virus, filterable forms off bacteria and bacterial products like toxins and pyrogens are not removed 3. Filter may break down suddenly or gradual faults may not be dectected 4. Clogging 5. Adsorption 6. Cannot be used for suspensions 7. Shedding of fibers 8, Suitable only for solutions Ceramic filters + Also called filter candles + Made up of porcelain or kieselguhr + Available in a range of pore sizes ‘« Numbered according to pore size Examples: Berkefeld filters and Mandler filtersBerkefeld filter ‘* Made up of unglazed porcelain or kieselguhr + Hollow cylinder candles mounted of metal joints * Candles can be sterilized by moist heat Ye 3 2 g 2 Praje4108 YSNUE .6 xz) + Clogging can be cleaned by scrubling the exterior with a nail brush or soft brush Advantages «+ Relatively inexpensive «Can be used for thermolabile substances * Various porosities are available Disadvantages + May get clogged + Requires cleaning after every process * Leaks occur at nozzle joints * Difficult to fill into filter units * Relatively high pressure needle for filtration Sei Iter/ fibrous pad filter © 3mm thick * Consists of two parts * Lower part holds perforated disc * On top of itis a compressed filter sheets compased mainly of asbestos fiber with other fibrous material such as wood cellulose to give adequate porosityes SJ Sintered metal filterSummary * Filtration removes, rather than destroys, microorganism * Used in the sterilization of heat-sensitive liquids * It also clarifies along with filtration + Filtration is also used for sterilization of air and other gases for supply to aseptic areas + Filtration requires aseptic procedures © Materials sterilized by filtration requires sterility testing