Clinical and biological Waste
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1 Health and Safety Services Safety Cde f Practice 14 Part 7 Clinical and bilgical Waste Office f the University Secretary
2 Cntents 1. Scpe Respnsibilities University wide Duties n Heads f Schls and managers Principal Investigatrs Labratry wrkers Training Clinical waste Bilgical and GM waste Autclave sterilisatin f labratry wastes Maintenance and Examinatin Validatin and Calibratin Rutine mnitring Waste packaging, transprtatin and identificatin Chemical disinfectin Further advice and infrmatin...8 Appendix 1 Summary f key clinical and bilgical waste streams...9 Gretta Rberts Bilgical & Scientific Safety Adviser Health and Safety Services Office f the University Secretary Tel st Editin Health and Safety Services ii
3 1. Scpe Bilgical and clinical waste frm research and teaching labratries must be segregated int a number f waste streams t meet legislative requirements and University envirnmental plicies and t reduce csts. These labratries generate wastes that must be decntaminated befre dispsal as they cntain, r may cntain, hazardus micrrganisms r because they cntain genetically mdified rganisms. This dcument prvides guidance n hw bilgical and clinical waste frm labratries shuld be segregated and decntaminated, prir t dispsal via an apprpriate dispsal rute. See als Safety Cde f Practice 28 fr details f dispsal rutes fr hazardus waste, including discharges frm labratry sinks. 2. Respnsibilities 2.1. University wide The Sub-Cmmittee fr Bilgical Safety is respnsible fr apprving the University s plicy n bilgical & clinical waste, and fr mnitring cmpliance thrugh peridic audits. Facilities Management Directrate, and its waste cntractr, is respnsible fr supplying waste services in accrdance with this CP, and in particular the adptin f the waste classificatin/clur cding scheme and dispsal rutes Duties n Heads f Schls and managers Heads f Schls and ther managers have respnsibility fr ensuring that: lcal rules are in place fr managing bilgically hazardus wastes, including disinfectin plicies and prcedures all staff and research students receive apprpriate infrmatin, instructin and training t enable them t fllw lcal rules Principal Investigatrs Principal Investigatrs must ensure that: activity risk assessments identify decntaminatin and dispsal methds fr all frms f hazardus waste prduced. where activities invlve bilgical agents in Hazard Grup 2 r abve, r any genetic mdificatin (GM) wrk, then these risk assessments must be reviewed and the wrk apprved by the Sub-Cmmittee fr Bilgical Safety. all wrkers under their supervisin are given sufficient infrmatin, instructin and training regarding waste segregatin, decntaminatin and dispsal prcedures fr managing waste are fllwed Labratry wrkers Labratry wrkers have a duty f care t ensure that waste is managed prperly and dispsed f safely via the crrect waste stream. Waste streams must nt be mixed. Health and Safety Services 1
4 3. Training All new members f labratry staff and students shuld receive training in lcal waste dispsal prcedures as part f their inductin. All staff and students shuld be made familiar with the labratry lcal rules specifying waste dispsal prcedures and any specific prcedures required under GM r Bilgical agents risk assessments. 4. Clinical waste Clinical waste cnsists whlly r partly f human r animal tissue, bld, excretins r any ther bdily fluids and any ther waste which has cme int cntact with any f the abve including plastics and syringes. There are five separate clinical waste streams: Table 1 Clinical waste streams Clur cding Waste stream Yellw clinical waste fr incineratin nly, in a suitably permitted r licenced facility. Orange - clinical waste fr alternative treatment t render it safe (ff-site autclave r micrwave treatment). May als be dispsed f by incineratin, in a suitably permitted r licenced facility. Tiger ffensive/hygiene waste including animal bedding. Dispsal is via deep landfill r municipal incineratin a suitably permitted r licenced facility. Purple-tpped (r slid purple) - cyttxic and cytstatic waste, fr incineratin at a suitably permitted r licenced facility Blue medicinal waste, fr incineratin at a suitably permitted r licenced facility Typical wastes generated in University facilities are listed in Table 2 verleaf, with an indicatin f the apprpriate waste stream. See als Appendix 1. Infectius clinical waste must never be sent fr dispsal t landfill. A system must be in place t ensure the safe transprtatin and strage f clinical waste, including ensuring that all clinical waste carts are lcked r lcated in a lcked cmpund. Materials knwn, r highly likely t cntain, Hazard Grup 3 pathgens are nt permitted in University labratries withut the express permissin f the Sub-Cmmittee fr Bilgical Safety and then nly in suitable labratry facilities. Health and Safety Services 2
5 Table 2 Typical clinical wastes Human & Animal Tissues Clinical waste nt knwn t be infectius, and is nt genetically mdified can be dispsed f in the range alternative waste stream. This includes glves, blue rll, plastics and packaging that have been cntaminated with clinical materials. Slightly sharper bjects such as pipette tips, transfer pipettes, graduated pipettes etc shuld be dispsed f in bxed range bags (range cardbard uter, range heavy duty plastic liner) r in range cardbard Bi-bins placed inside range bags. The bxed bags must nt be used fr the dispsal f any item which culd pierce the range bag cntained within the cardbard bx and shuld nt be filled t mre than ¾ full. Cntaminated sharp bjects such as syringe needles, micrscpe slides, Pasteur pipettes, scalpels etc shuld be dispsed f in range tpped sharps bins. The infrmatin panel n sharps bins must be cmpleted befre being cllected fr dispsal. Sharps bins shuld nt be ver filled. Where clinical waste cnsists f human r animal tissue, r is reasnably suspected t be infectius then the yellw (incineratin nly) waste stream shuld be used. Anatmical waste Animal husing Includes (animal) bdy parts, ther recgnisable anatmical items and carcasses. Shuld be stred frzen and dispsed f by incineratin (yellw waste stream) using the University waste dispsal cntractr. Animal bedding may be dispsed f as ffensive waste (tiger bag stream, yellw/black) and sent fr nn-hazardus landfill, IF the animals are nt knwn t be infected with hazardus micrrganisms. Where animals are knwn t be infected with a hazardus micrrganism, items such as cages, bedding, drinking bttles and ther items shuld be decntaminated by autclaving r chemical disinfectin befre dispsal using the tiger bag waste stream. Cyttxic and cytstatic waste Medicinal waste Any waste that is, r is cntaminated by cyttxic r cytstatic medicines (fr example any medicines that are either: txic, carcingenic, mutagenic r txic fr reprductin such as hrmnal preparatins, sme anti-viral drugs, antineplastic agents, immunsuppressants and sme antibitics), shuld be placed in purpletpped clinical waste bins and dispsal arranged via University waste dispsal cntractr. Any medicines (excepting cyttxic r cytstatic medicines), pharmaceutical prducts, drugs, vaccines, sera, and discarded items used in the handling f pharmaceuticals, such as packaging cntaminated with residue, glves, syringe bdies, drug vials etc shuld be placed in blue/blue-tpped bins and dispsal arranged via University waste dispsal cntractr. Health and Safety Services 3
6 5. Bilgical and GM waste Bilgical waste cnsists f, r material cntaminated with bilgical agents (i.e. micrrganism, cell culture, r human endparasites which may cause any infectin, allergy, txicity r therwise create a risk t human health ). This includes waste frm bacterilgy, virlgy and tissue culture labratries. Genetically Mdified Organisms (GMO) waste - cnsists f, r material cntaminated with genetically mdified micrrganisms, cell cultures r ther (higher rganisms) which may cause any infectin, allergy, txicity r therwise create a risk t human health r t the envirnment. All waste cntaminated with GMOs must be inactivated by validated means befre dispsal. The waste rutes must be specified in the risk assessment and lcal rules. All risk assessments are apprved by the Sub-Cmmittee fr Bilgical Safety. A summary f the recmmended dispsal rutes is given in Table 3 belw: Table 3 Typical bilgical and GM wastes Waste frm: Hazard Grup 1 & 2 Bilgical Agents r Class 1 & 2 GMOs Waste frm Cntainment Level 3 labratries Liquids Slids Serlgical pipettes and pipette tips Glass Pasteur pipettes Sharps HG1/Class 1: Liquids can be disinfected with apprpriate chemical disinfectant and dispsed t drain. Alternatively liquids may be autclaved befre dispsal t drain. HG2/Class 2: Liquids shuld be treated with disinfectant and transferred t autclave fr sterilisatin. Sterilised liquids can be dispsed f t drain. Place in clear autclave bag. Autclave. Dispse f sterilized waste in black bin liners and place in skip fr landfill. Place in rbust cntainer (such as dispjar). Autclave. Dispse f sterilized waste in black bin liners and place in skip fr landfill. Place in rbust cntainer. Autclave. Dispse f sterilized glass in glass bin. Placed in range-tpped Sharps bin. Autclave. Place with clinical waste fr final dispsal. Dispsal rutes must be specified in the Lcal Rules fr the facility. Health and Safety Services 4
7 6. Autclave sterilisatin f labratry wastes The requirements fr autclaves fr the sterilisatin f labratry wastes are specified in the ACDP guidance The management, design and peratin f micrbilgical cntainment labratries 2001 and in the Genetically Mdified Organisms (Cntained Use) Regulatins 2000 (as amended 2005). Autclaves must be designed, installed and maintained in accrdance with the Prvisin and Use f Wrk Equipment Regulatins 1998 and Pressure Systems Safety Regulatins Detailed infrmatin n labratry autclaves can be fund in BS 2646 Autclaves fr Sterilizatin in Labratries and BS EN Bitechnlgy: Perfrmance criteria fr steam sterilizers and autclaves. In line with the abve guidance, autclaves are required in the fllwing lcatins: Table 4 Requirements fr autclaves Cntainment Level Cntainment level 1 Cntainment level 2 Cntainment level 3 Requirement fr autclave treatment Waste must be treated n-campus. If the autclave is lcated in anther building, steps must be taken t ensure cntainment f the lad during transprtatin. Autclaves fr shuld be readily accessible in the same building. Autclave shuld be preferable be situated within the labratry. Where this is nt reasnably practicable it shuld be in clse prximity t the labratry and steps made t ensure safe and secure transprtatin Maintenance and Examinatin Peple in charge f autclaves must ensure that installatin is ntified t, and a maintenance and examinatin scheme agreed with, the Facilities Management Directrate Validatin and Calibratin Validatin tests the ability f the autclave t effectively decntaminate with typical userdefined lads. Autclaves that are used t deactivate bilgical r GM waste must have the prcess f deactivatin validated at least annually. Fr autclaves treating waste frm cntainment level 3 labratries this must be at least 6-mnthly, with cnsideratin given t 3 mnthly validatin. Where the typical lad changes, further validatin must be carried ut. Recrds f validatin shuld be kept fr 5 years. Fr validatin a mck wrse case lad shuld be simulated and temperature prbes inserted at varius psitins (usually 12 pint thermcuple). These are attached t recrding equipment which takes readings thrughut the decntaminatin prcess. The validatin tests Health and Safety Services 5
8 shuld be carried ut by a cmpetent engineer using calibrated equipment in accrdance with the relevant British Standard. In additin, autclaves require calibratin, and thrugh examinatin and testing as a pressure system. Calibratin is a prcess which checks that the autclave cntrl panel is crrectly cntrlling and indicating the varius autclave perating parameters. This is ften carried ut in cnjunctin with validatin and/r servicing. Thrugh examinatin and testing cnfirms that the autclave and its pressure-related safety devices are safe. Table 5 Validatin, Calibratin and Examinatin and Test requirements fr autclaves Waste frm Cntainment Level Cntainment Level 1 Cntainment Level 2 Cntainment Level 3 Validatin Frequency Annual At least annually 6 mnthly recmmended if indicated by risk assessment At least 6 mnthly 3 mnthly recmmended if indicated by risk assessment Servicing and Calibratin Frequency In accrdance with manufacturer s instructins nrmally 6 mnthly Thrugh Examinatin and Test (as a pressure system) Every 14 mnths 6.3. Rutine mnitring Autclaves shuld be fitted with chart recrders r alternative devices fr recrding run parameters. These shuld be checked and kept fr each sterilisatin run t ensure that the autclave cntinues t perfrm satisfactrily. This prcedure must nt be used as a replacement fr decntaminatin validatin. Nte: autclave tape indicates that the temperature at the lcatin f the tape reached a certain temperature rather than a lad has been sterilised effectively. Table 6: Minimum recmmended autclaving cnditins fr decntaminatin f waste Temperature Pressure Sterilisatin Time ºC 15 psi 15 mins 134 ºC 30 psi 3 mins Clear succinct perating instructins, including instructins n prcedures t fllw in the event f an emergency (including spillage, autclave failure, etc) must be available t, and understd, by each peratr. Operatrs shuld als make weekly checks f the prper functin f all safety devices. Particular attentin shuld be paid t dr seals. Any leak shuld be attended t as sn as practicable. Health and Safety Services 6
9 6.4. Waste packaging, transprtatin and identificatin A system shuld be in place t facilitate cllectin f items fr sterilisatin frm labratries and the cntained and secure strage f these prir t treatment. Autclave bags used fr sterilisatin shuld be clear r translucent s that incrrect items can be easily detected. Autclave bags shuld be clearly labelled with bihazard. They shuld be placed in apprpriate hlders in the labratries with integral drip trays. Bags ready fr sterilisatin shuld be sealed and remved t a clearly labelled cllectin pint within the labratry. Bttles cntaining cntaminated liquids (treated with disinfectant as apprpriate) shuld be sealed with fil. All waste shuld be transprted t the autclave rm in rigid sealed cntainers t cntain any leaks, and shuld be clearly labelled with the riginal labratry details. Waste shuld nly be transprted t the autclave rm immediately prir t treatment and care shuld be taken t prevent stckpiling f waste. Waste must nt be left in unsecured lcatins (including crridrs). Arrangements must be made t ensure that general cleaning staff knw nt t handle this waste. Nte: Liquids cntaining radiactive material, txic r flammable chemicals shuld nt be autclaved and may require alternative treatment. This treatment must be cnsidered n a case-by-case basis. Cntact H&S Services fr mre advice. 7. Chemical disinfectin Chemical disinfectin may be used rutinely fr the decntaminatin f liquids cntaining Hazard Grup 1 and Class 1 genetically mdified micrrganisms. It is recmmended that HG2 and GM Class 2 liquid wastes are chemically disinfected in the labratry prir t transprtatin frm the labratry t the autclave. Chemical disinfectin in the labratry prir t transfer t the autclave is required fr HG3 and Class 3 GM. The fllwing pints shuld be cnsidered when selecting disinfectants: All disinfectants are hazardus substances in their wn right. Disinfectants with the lwest risk t human health pssible shuld be used where practical, in accrdance with the principles f COSHH. Where practical liquid r tablet frms shuld be purchased in preference t pwder frms t prevent inhalatin. Efficacy the spectrum f activity f disinfectants varies against different micrrganisms, users must check with the manufacturers activity data. cntact time sufficient time is required fr the disinfectant t be in cntact with the material t enable effective decntaminatin. cncentratin the FINAL DILUTION shuld be taken int accunt when disinfecting liquids t ensure that the cncentratin f disinfectant remains in the effective range. disinfectants can be affected by factrs such as the presence f rganic matter, chemicals, ph, temperature and age. Health and Safety Services 7
10 Validatin disinfectants shuld be used in accrdance with manufacturers instructins. Fr HG r Class 3 materials the disinfectant must be validated under wrking cnditins using in-huse experimental data. Types f disinfectants available include: Hypchlrites Chlrine based disinfectant which is highly effective against vegetative bacteria, viruses and fungi. Inactivated by rganic matter. Has limited shelf life. Shuld nt be mixed with acids r frmaldehyde as txic gas is released. Incmpatible with catinic detergents. Crrdes sme metals and damages rubber. Recmmended cncentratin 2500 ppm fr discard jars. Perxygen disinfectants (e.g Vikn) Wide ranging efficacy against bacteria and viruses, may cause crrsin n metal. Virkn is available in liquid, tablet and pwder frm (nte the pwder is a respiratry irritant). The slutin has a built-in clur indicatr can be stable fr up t 7 days when diluted and must be replaced when clur fades. The usual effective dse is 2% final cnc. Highly cncentrated slutins have reduced efficacy (>4%). Autclaving shuld be avided r nly undertaken in an autclave that is cnnected t the mains water supply and that is externally exhausted as Virkn can generate sulphur dixide when heated. Trigene Advanced This is a micr-emulsin disinfectant with brad-range bacterial and virucidal activity. Trigene is available as a lw-hazard slutin with a diluted shelf life f 6 mnths. Fr disinfectin f liquids a final cncentratin f 10% is recmmended. 8. Further advice and infrmatin ACDP guidance The management, design and peratin f micrbilgical cntainment labratries Genetically Mdified Organisms (Cntained Use) Regulatins 2000 (as amended 2005). Prvisin and Use f Wrk Equipment Regulatins Pressure Systems Safety Regulatins BS 2646 Autclaves fr Sterilizatin in Labratries. BS EN Bitechnlgy: Perfrmance criteria fr steam sterilizers and autclaves. BS EN 12740: Bitechnlgy. Labratries fr research, develpment and analysis. Guidance fr handling, inactivating and testing f waste. Safe management f healthcare waste. Versin 2.0 England. Department f Health, March Wrking with Bilgical Agents. Medical Research Cuncil Health and Safety Services 8
11 Appendix 1 Summary f key clinical and bilgical waste streams Waste categry Waste stream & clur cding Material Nn-hazardus waste Black Bag Safe Waste Recycling Dedicated glass bin Paper, card, uter packaging frm labratry cnsumables Paper twels frm handwashing Nn-hazardus plastic chemical cntainers (rinsed ut and labels remved) Winchesters, sme plastic chemical bttles (rinsed ut and labels remved, unless therwise instructed by the recycling cmpany/supplier) Uncntaminated brken glass Clinical waste Fr alternative treatment - nt knwn t be infectius Clinical waste range bags r bxes Clinical waste range bibins Clinical waste range sharps bin (NB may be yellw with range lid) Clinical waste which requires incineratin incineratin bins Tiger ffensive/hygiene waste fr landfill Purple-tpped (r slid purple) - cyttxic and cytstatic waste, fr incineratin Blue - medicinal waste fr incineratin Glves, dispsable plastics (nt sharp) such as centrifuge tubes, flasks, micr-titre plates. (Serelgical) pipettes and pipette tips Needles and syringes, glass slides and cver slips, scalpels, glass pasteur pipettes. Anatmical waste (human/animal, infected r uninfected) Bld and ther bdily fluids (cntained t prevent leakage) Sample (bld) cllectin tubes All nn-hazardus, nn-infectius lab cnsumables and ther materials which may cause ffence t thse cming int cntact with it e.g. may cntain recgnisable lab waste items r bdily fluids, animal faeces and bedding etc. Cyttxic and cytstatic waste. Defined as any medicinal prduct that pssesses ne r mre f the fllwing prperties: H6: Txic; H7: Carcingenic; H10: Txic fr reprductin H11: Mutagenic May als be cntaminated with bilgical material. Nn-cyttxic and cytstatic waste, including unused r expired pharmaceutical prducts and lab supplies & packaging cntaminated with residues. Bilgical waste Nte: all waste fr autclaving must be labelled Chemical disinfectin and sewer Chemical disinfectin recmmended in the labratry, then autclave sterilisatin and sewer GM class 1 liquids and HG 1 liquids GM class 2 liquids, HG 1 liquids Health and Safety Services 9
12 Waste categry Waste stream & clur cding Material as bihazard. Bilgical waste - autclave bags (clear) Final dispsal via black bin waste OR as Tiger waste if deemed t be ffensive Autclave jars Autclave cntainers Slid waste cntaminated with all GM rganisms Slid waste cntaminated with HG1-3 micrrganisms e.g. Glves, dispsable plastics (nt sharp) such as centrifuge tubes, flasks, micr-titre plates, petri dishes, GM sil and plant material, tissue culture cntaminated waste (Serlgical) pipettes and pipette tips Glass pasteur pipettes Health and Safety Services 10
13 Nte: Municipal waste Occasinally small quantities f clinical waste frm municipal i.e. nn-labratry, surces, may need t be dispsed f (fr example needles and swabs frm csmetic bdy art r piercing, drug litter, minr first aid supplies such as cntaminated dressings r bandages, human and animal hygiene wastes). Where this waste is generated in a nn-labratry envirnment, and where they are similar t husehld wastes, it is permissible t dispse f them in the general, black bag, waste. Hwever sharps must be dispsed f safely, even if nt cntaminated with bdy fluids, and hence the range sharps bins fr clinical waste shuld be used. Where generatin f these types f waste is a regular ccurrence, cnsideratin shuld be given t implementing a clinical waste stream. Health and Safety Services 11
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