1 IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKINGMould and Mildew Remover for household use. LTPTone Industrial EstateMilverton RoadWellingtonSomersetTA21 0ANTel: 01823 666213Fax: 01823 665685Irritating to skin. Risk of serious damage to eyes. Contact with acids liberates toxic gas. CLASSIFICATION (1999/45)ENVIRONMENTThe product contains a substance which is very t
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Untitled012-014crt0210 Shieldfeature:cltnews 4/3/10 14:59 Page 12 medicinal products are to be manufactured.
hazardous means that, under Control ofSubstances Hazardous to Health (COSHH)regulations, employers in the UK are obligedto assess the risks.3 Additionally, concernsregarding the possible carcinogenicity ofsome anticancer drugs means they aresubject to Appendix 1 of the COSHHApproved Code of Practice (ACOP).3 Foroperators engaged in the preparation andhandling of chemotherapy drugs, the mostcommon form of exposure is via dermalcontact and inhalation.3 Even intact skin isvulnerable4 and some chemotherapy drugsare skin irritants.3 consideration needs to be given to: ● the toxicity of the cytotoxic drug ● the time of exposure to the drug ● the frequency of the exposure to the drug. contact during the preparation andadministration of drugs, paying particularattention to the glove specification and howit relates to personal protection seems Handling prudent, particularly as the cumulative effect of regular exposure to small doses ofcytotoxic drugs3 is not fully understood. Handling compounds is carried out in enclosed units such as isolators, potential exposure wouldappear to be limited to the barriereffectiveness of the gloving system. Awayfrom the production unit, skin contact could cytotoxic result from surface residues on packaging or (PPE) at Work Regulations (1992),appropriate PPE needs to be provided whenthere are no other alternatives to managing material the risks.3PPE obviously includes hand protection, which gives rise to the questionof how to determine the suitability of thegloves. Where the intended purpose ispersonal protection, it would seem logical toselect a glove registered according to the PPEDirective (89/686/EEC) rather than the The level of protection afforded by gloves to Medical Device Directive 93/42/EEC wherethe emphasis is on patient protection.6 personnel and products when handling cytotoxic agents is complex. Nick Gardner, SHIELD
chemical hazards, selecting gloves designedto protect against the highest level of risk will Scientific, offers some important considerations be necessary. These gloves are referred to asgloves of complex design (category III) for With the 25% increase in cancer in and teratogenic.2 The potentially hazardous irreversible or potentially mortal risk.6
Determining the regulatory status of a glove attention of the UK Health & Safety Executive the forefront of our defence for tackling this (HSE), which has published two information Conformity (the latter is a legal obligation preparation and handling of cytotoxic agents under the PPE Directive) and the details will often feature on the product data sheet. The gloves’ ability to resist permeation led to the International Agency for Research product protection is tightly controlled by and penetration of cytotoxics is important4 on Cancer (IARC) classifying some cytotoxic the EC Guide to GMP,5 which stipulates the and requires the following considerations: drugs as possibly carcinogenic, mutagenic Permeation – defined as “the process by www.cleanroom-technology.co.uk
012-014crt0210 Shieldfeature:cltnews 4/3/10 15:00 Page 13 pharmaceuticals
Table 1: Key differences between standards
ASTM F 739-99a
What to test?
guidance is given on the selection of cytotoxic drugs Area of glove
needs to be tested
contact (i.e. the palm or cuff) is to be tested. Table 2: Comparison of carmustine and thiotepa
TEST 1: EN 374-3:2003
TEST 2: ASTM D6978-05
Table 2. If a risk assessment had been based on EN374-3: 2003, then it could have given the glove wearers a higher level of confidencein the glove’s resistance to permeation by Table 3: Annex A (EN374-2: 2003) Quality Assurance specifically developed
Procedure to be used in glove manufacture9
not the only factors that govern permeation; Performance Acceptable
permeation characteristics of a glove, only level (AQL) unit
considered – this can apply when looking at various formulations of gloves from the same which a chemical agent migrates through the A further cautionary note on assessing the protective glove at a molecular level”.7 Those methodology is more aligned with the needs disinfecting gloves in use will diminish their assessing the permeation characteristics of a glove, will inevitably seek data specific to temperature of 35°C (+/-2°C) is close to that of the human hand, and it should be noted that permeation accelerates with increasing temperature. In view of the hazardousness of Penetration – this is described by the HSE as “the bulk flow of a chemical agent through ● ASTM D6978-05 “Standard Practice for closures, porous material, seams, pinholes Assessment of Resistance of Medical Gloves highest level of sensitivity as defined by permeation rate – 100 times more sensitive glove”.7 The issue of penetration has been ● ASMT F739-99a “Standard Test Method for Resistance of Protective Clothing Materials stipulates the cytotoxic agents and their positive pressure, as there is greater potential ● EN374-3:2003 “Protective gloves against chemicals and micro-organisms – Part 3: rubicin HCI, etopside, fluorouacil, paclitaxel Determination of resistance to permeation and thiotepa), while two can be selected by against cytostatics are likely to be registered methodologies for chemical permeation, in trations are detailed for optional testing. preferred method, presumably because it is a mentions that only the thinnest part of the disposable gloves this will invariably mean that the gloves will have undergone a ᮣ www.cleanroom-technology.co.uk
012-014crt0210 Shieldfeature:cltnews 4/3/10 15:00 Page 14 pharmaceuticals
watertight test and the porosity of a glove is The product data sheets for these types of gloves will often provide details in terms of specification and typical levels of particles considered to be micro-organism resistant if content of less than 20 EU/pair of gloves as Level (AQL) of 1.5 or Level 2. An AQL of 1.5 accepts the statistical probability that there Further guarantees of the suitability of the are less than 1.5% defects in a batch of gloves.
batch specific data that is provided in the form assurance level, giving the glove wearer a of a certificate of analysis or certificate of conformance. Specifically, with reference to barrier defects such as pinholes, AQL is an important parameter for minimising the risk penetration,8 sourcing gloves with as low an represents a statistical probability of defects, a lower AQL is better for assuring process protection particularly when working under personal safety are local safety standards.
The value of cleanliness – particle and non-sterile protective gloves will need to be extractable data are not routinely provided for surgical gloves, but are for cleanroom preparation of cytotoxic drugs. They include: Most of the criteria already discussed still gloves. High particle counts on gloves may ● Berufsgenossenschaft für Gesundheit und apply, but noting that non-sterile gloves are often thinner and may not have been tested association for the German health service specifically on cytotoxic drugs.8 The most packaged in paper-free packaging to reduce ● TRGS 525 Technical rules for working with protect the wrist fully from drug exposure.
contamination are particularly relevant to aseptic processes and it has been reported ● Suva (Schweizerische Unfallversicherungs- that “the pyrogens that pose most risk to the ● Institute for Applied Healthcare Sciences (IFAHS) – Quality Standard for the Pharmacy rigours of being left on an isolator ring. Not contamination are particularly high as gloves all synthetic gloves may be as suitable as latex, with its superior elasticity. Size range ment, which promotes the proliferation of (particularly with reference to smaller and Gram-negative bacteria. Also water used for larger sizes) and fit will need to be evaluated.
washing the gloves may be laden with micro- ● Toxicité et risques professionnels. Fiche The importance of safety in use should not ● Recommendations pour la prévention des preventing spillages – a glove in contact with isopropyl alcohol can become very slippery. endotoxin content claim and particularly if it is batch tested for endotoxin is likely to be of Here too there are differences in guidance Product protection
(see footnote). For example, glove wearing Annex 1 to the EC Guide to GMP stipulates that “the manufacture of sterile products is are inflammatory substances not eliminated some variation in practice. It is notable that subject to special requirements to minimise the BGW mentions “occlusion” as a reason risks of microbiological contamination, and irritant contact dermatitis and have been for changing gloves every 30min.11 This is of particulate and pyrogen contamination”.5 To achieve these objectives, different levels of airborne particles are prescribed for various In conclusion, gloves play a vital role in it easier for the cytotoxic drugs to come levels of cleanliness. However, what about providing personal and product protection into contact with the skin. Double-gloving for additional protection through a double contact with the product? Some authorities consideration. CT
wall system is widely practised.8 However, refer to the use of “clean gloves” for use in the isolator,4 without indicating what is clean.
coloured gloves to help rapid detection of For a fuller version of this article with the references and sterilised by gamma irradiation to Sterility additional tables visit the Cleanroom Technology website at So far, we have looked at hand protection Assurance Level (SAL) of 10-6 (in accordance in enclosed units, where sterile gloves of longer length (28–30cm) are likely to be used.
ISO 11137:2006 “Sterilization of Healthcare Products – Radiation”), it could still be a Nick Gardner, MBA
could result from surface residues on the SHIELD Scientific
seems prudent to use gloves that have been specifically developed for cleanroom use.
NTP 31: Actos de las instituciones de las Comunidades Europeas como fuentes del derecho comunitario Acts of the Institutions of the European Communities as a source of Community Law Actes des Institutions des Communautés Européennes comme source du Droit Communautaire Vigencia Actualizada por NTP Observaciones ANÁLISIS Criterios legales Criterios técnicos Operativos: