Зірочка з нержавіючої сталі #25 | Відповідає стандартам GMP для фармацевтичних ліній

ANSI 25 stainless steel sprocket in 304 or 316 SS — validated for GMP pharmaceutical packaging and tablet-handling conveyors. Includes mill test report, CMM record, and optional electropolish to Ra ≤ 0.8 µm. Replaces Martin, Tsubaki, and Rexnord #25 units on lines where contamination has zero tolerance.

Опис

Ханчжоу Ever-Power Sprocket Co., Ltd.

A pharmaceutical packaging line runs under GMP. Every component in the product zone is subject to material qualification, surface finish specification, and contamination risk assessment. The sprocket is not an exception.

The GMP Engineer’s View of a Conveyor Sprocket

In a pharmaceutical packaging line, the validation engineer’s job is to prove that every material in contact — or potential contact — with the product or its primary packaging does not introduce contamination risk. A sprocket that sits inside a blister-pack transfer conveyor, or beneath a tablet-counting machine, or driving an inspection-station indexer is not “just a mechanical component.” It is a material that must be qualified, surface-finished to a measurable standard, documented with traceable chemistry data, and capable of being cleaned and verified clean between product campaigns. The Зірочка з нержавіючої сталі Ever-Power #25 is built to satisfy exactly that qualification process. Grade-certified stainless, polished to Ra ≤ 1.6 µm as standard and Ra ≤ 0.8 µm electropolish on request, with a heat-specific mill test report and CMM dimensional record supplied as standard — not as a premium option.

#25 ANSI stainless steel sprocket pharmaceutical GMP

Surface Finish Standards and What They Mean in Practice

Surface roughness (Ra) is the parameter that determines bacterial retention on a stainless surface. Smooth surfaces clean more completely, faster, and with less cleaning agent — which reduces residue risk and makes validation of the cleaning process easier to document. Understanding which Ra level your line requires helps you specify correctly from the start:

Ra ≤ 3.2 µm — As-Machined

Suitable for non-product-contact zones and enclosed drives. Not recommended for surfaces that must be validated clean between batches.

Ra ≤ 1.6 µm — Mechanical Polish

Our standard finish. Meets the majority of pharmaceutical conveyor specifications and FDA/EMA guidance on surface finish for non-direct-contact equipment components.

Ra ≤ 0.8 µm — Electropolish

Required for EHEDG-certified equipment and high-containment or sterile manufacturing environments. Reduces bacterial adhesion by up to 30% vs. mechanical polish. Specify on order.

Технічні характеристики

Параметр Значення
№ ланцюга ANSI 25
Крок 6,35 мм (1/4 дюйма)
Матеріал 304 СС / 316 СС
Діапазон зубів 9T – 72T
Standard Finish Ra ≤ 1.6 µm
EP Option Ra ≤ 0.8 µm electropolish on request
Документація MTR (heat-specific) + CMM report, standard

Cleaning Validation: What the Maintenance Team Needs to Know

Pharmaceutical maintenance teams run cleaning validation on equipment that contacts the product environment. A stainless steel sprocket at Ra ≤ 1.6 µm can be validated clean using standard swab or rinse methods against visual and chemical residue limits. The electropolished variant (Ra ≤ 0.8 µm) typically achieves lower swab recovery values with less cleaning agent, which simplifies the validation protocol and reduces the number of cleaning cycles required for acceptable residue levels. Passivation treatment (citric acid per ASTM A967) is included free of charge on all pharmaceutical orders — this maximises the chromium oxide layer and eliminates free-iron contamination from machining tooling that could otherwise produce rust spots under steam cleaning.

Stainless steel sprocket pharmaceutical packaging application

Companion Components for GMP Conveyor Drives

GMP stainless conveyor drive components

Qualification is easier when the entire зірочка з нержавіючої сталі drive assembly comes from one supplier with one quality system and one documentation standard. We supply matched components:

  • Роликовий ланцюг ANSI 25 SS — 316 SS for maximum cleaning resistance, per-foot or 10 ft lengths
  • SS Connecting Links — electropolished versions available to match sprocket finish spec
  • Зірочки натяжного колеса SS — plain-bore, same material and finish grade as the drive sprockets
  • Кріплення з нержавіючої сталі A2-70 — non-magnetic, no particle-shedding plating
  • Passivation Certificate — ASTM A967 treatment record for validation file inclusion

What Pharmaceutical OEM Customers Report

★★★★★

“MTR and CMM report were in the package — exactly the format our validation team needed for the equipment file. Electropolish finish confirmed by Ra measurement on arrival. Zero rework, zero delay to our validation timeline.”

— Validation Engineer, Solid-Dose OEM, Switzerland

★★★★★

“We qualified Ever-Power as an approved supplier for #25 SS sprockets on our tablet-coating conveyor line. Three years on, no deviations, no non-conformances on incoming inspection. Consistent batch to batch.”

— Procurement Manager, Pharmaceutical OEM, Germany

★★★★☆

“Passivation certificate was included without being asked — that saved us a step in the documentation process. Surface finish on the bore was clean; the keyway was cut correctly first time.”

— Equipment Engineer, CMO Facility, Belgium

Get a GMP-Ready Quote

Specify your surface finish, documentation requirements, and bore size — we quote within 24 hours.
+86-571-88220653 | [email protected] | ШЕНЬХУА РОУД, ХАНЧЖОУ, КИТАЙ

Запит цінової пропозиції

Дивитися повну версію асортимент зірочок з нержавіючої сталі or learn about our facility at the Сторінка «Про нас».

Часті запитання

1. What documentation is needed to include a sprocket in a pharmaceutical equipment qualification file? +
Typically: material grade certificate (MTR/EN 10204 3.1), surface finish specification and measurement record, dimensional report, and passivation treatment certificate. We supply all four as part of our standard pharmaceutical order package. If your site requires additional documentation (e.g., oxalic acid etch test for sensitization per ASTM A262), advise us at order stage.
2. Is 304 or 316 SS specified for pharmaceutical lines? +
316 SS is the standard specification in most pharmaceutical guidelines (ISPE, GAMP) for equipment in direct or indirect product-contact zones. 304 SS is acceptable for fully enclosed drives with no cleaning requirement; where cleaning validation is performed, 316 is required for its superior resistance to the cleaning agents commonly used.
3. Can Ra be measured and certified on delivery? +
Yes. Surface roughness measurement records (Ra value, measurement location, instrument calibration reference) are available on request. Specify “Ra measurement certificate required” in your order and the report ships with the goods.
4. How do I specify the correct tooth count for a tablet-transfer indexing drive? +
Provide us with your drive ratio (input to output speed), centre distance, and shaft diameters. We recommend 17T minimum on the driver for smooth engagement and low chordal action — important on indexing drives where position accuracy matters. We can provide a full drive calculation if needed.
5. What is your lead time for custom bore pharmaceutical sprockets? +
10–15 working days for custom bore and tooth count, including electropolish and passivation. Documentation is prepared in parallel and does not extend the lead time. Contact us early — pharmaceutical projects often have fixed commissioning dates and we can schedule accordingly.

Відгуки

Відгуків немає, поки що.

Будьте першим, хто залишив відгук на “#25 Stainless Steel Sprocket | GMP-Ready for Pharmaceutical Lines”

Ваша e-mail адреса не оприлюднюватиметься. Обов’язкові поля позначені *