Pharmaceutical Cleaning Validation Training
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Pharmaceutical Cleaning Validation Training

Cleaning validation
Cleaning ValidationDemonstrating effective cleaning of equipment in order to eliminate product contamination is a critical FDA requirement.ERA is the leader in cleaning validation and verification products and services, including a proprietary technique for quantitatively depositing whole pharmaceutical product, actives (APIs) or detergents, on any surface our customers need.ERA has also developed a comprehensive visually clean program that offers customers a simple method to validate SOPs for visual residue limit (VRL) determination and analyst training applications.ERA is the premier manufacturer of specialty cleaning validation products.We provide coupons, certified clean sample vials and swabs for swab recovery studies, as well as kits that can be customized to suit your laboratory, analyst and validation needs.Additionally, ERA has developed a process to quantitatively coat just about any surface with your API, whole-product, detergent or process solutions.Call us today to discuss your application and how we can Order Organoleptic CouponsWhether for visual residue limit (VRL) determination or inspector training and certification, ERA is the leader in the uniform depositionof soils on surfaces of all types.

Contact our Custom Project Manager, John Laferty at 1-800-372-0122 to discuss your needs andhow he can help.ERTIFIEDLEAWABSCat.#30031Large Polyester Swabs with snap-off head for use with TOC.100 swabs (two bags of 50 each).

- Similar to TX714K.- Ultra-low interference levels ( 50.0 ppb TOC) Cat.#30030Large Polyester Swabs with snap-off head for use with HPLC.100 swabs (two bags of 50 each).- Similar to TX715.- Ultra-low interference levels (Abs254: 0.1 au max.)CV SWABBIPLATESCat.

#30028 (pack of 25)Cat.#30029 (pack of 25)Cat.#30032 (pack of 25)Cleaning Validation Productspg: 036

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2011ERA pre-cleaned Teflon swabbing templates are a simple way to ensure accuracy and precision in your cleaning validation sampling (stainless steel available upon request).

Each pack comes with a C of A for residual HPLC and TOC levels.Our disposable/reusable templates are available in 16, 25 and 100 cm areas or can be custom made to your needs (call for pricing and custom sizing).USTOOUPOFROM ERACat# 30024 Custom plastic or rubber coupon for cleaning validation.Cat# 30025Custom metal coupon for cleaning validation
pharmaceutical cleaning validation training
.Cat# 30027Custom glass coupon for cleaning –Metal, plastic, rubber or glass type (stainless steel,polyethylene, etc.).Grade –Specific grade of material; like 316 stainless, HDPE orborosilicate glass.Finish –Arguably the most important factor.The finish usually refers to the surface roughness and can be stated in terms of “grit” or “Ra” values for metals.It is most often measured using a profilometer.Coating –Most materials can be coated to offer desirable surface properties.Etching –Most materials can be etched with serial numbers, swabbingareas or other information.Durometer –A material density, or “hardness” value for rubber.Dimensions –Size and shape of the coupon.Thickness –You can request a certain thickness for your coupons or asuitable one will be chosen.Quantity –The quantity of coupons is the leading supplier of coupons for cleaning validation applications.We make coupons in all the standard materials you would expect, like stainless steel and glass, but go out of our way to service our customers' rarest requests – like glass-coated ceramics! Whatever your equipment or specific application, call ERA for your next coupon project and experience service from a team of professionals that understand your application.While every coupon order is treated as a custom request, only the experience is special; our pricing underscores the value of doing business with our life science experts.

Place just one order with ERA and you won’t ever go anywhere else for coupons.Cleaning Validation Coupons from ERA2011

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pg: 037CUSTO CLEANING VALIDATION KITS FOR RECOVERY STUDIES AND ANALYST TRAININGCustom Cleaning Validation analyst choice (metals, rubbers, choice and at concentrations you can specify as per specifications spikingareas for working range analyst and qualification and concentrations can be selected by ERA or your conjunction with blind sample kit optionsERA manufactures custom “cleaning validation” kits for swab recovery studies, swabbing validation and analyst training.The kits are very flexible and can include soils of chemicals provided either by you or by ERA.Call us for more information regarding how we can build a kit just for you.LEAALIDATIOPLIITSCat.#CV10000 Vial and Swab Sampling Kit25 certified clean swabs12 certified clean vialsCat.#CV10005Vial and Swab Sampling Kit160 certified clean swabs80 certified clean vialsCleaning Validation Products – Kitspg: 038

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