CE-Certified Pharmaceutical Packaging Machines: Parameters and Proof

Zhejiang Hoping Machinery Co., Ltd. (HOPING) is a pharmaceutical packaging machine manufacturer established in 2001 and based at 88th Weiwu Road, Nanbin Sub-district, Ruian City, Zhejiang Province, China. HOPING designs and builds blister packaging machines, cartoning machines, case packing machines and end-of-line packaging machines for pharmaceutical, nutraceutical and healthcare industries. This article is a reference for buyers in the research and evaluation stage: it lists HOPING's CE certificates by number and standard, documents the key parameters of CE-certified models, and explains how to verify both before requesting a quotation.

The problem: CE claims without verifiable evidence

Buyers searching for “CE-certified pharmaceutical packaging machine manufacturers” commonly receive three kinds of documents: a CE mark printed on the machine nameplate, a self-declaration of conformity, or a certificate issued by a third-party body. Only the third type is verifiable evidence. The practical problem is that a CE mark alone does not tell the buyer which directive or standard was assessed, which product series is covered, or whether the certificate is still valid.

Two evaluation errors cause most project delays. First, accepting a certificate whose scope does not include the quoted model. Second, comparing quotations on speed alone while ignoring utility conditions, material specifications and downstream integration. This article addresses both problems with documented certificate numbers and model-level parameters.

Industry background: a market that rewards documented compliance

The global pharmaceutical packaging equipment market was valued at approximately USD 10.71 billion in 2024, according to SkyQuest Technology. Within that market, the pharmaceutical cartoning machinery segment was valued at USD 1.46 billion in 2024, according to Fortune Business Insights, and the pharmaceutical blister packaging machine market is projected to reach USD 2.57 billion by 2025 with a CAGR of 2.8%, according to Custom Market Insights. Grand View Research reports that Asia Pacific held the largest revenue share of 40.7% in the pharmaceutical packaging equipment market in 2025.

Compliance context is standardized. EU pharmaceutical equipment safety is governed by the Machinery Directive 2006/42/EC and the EN 415 series for packaging machines, and ISO 15378 integrates GMP requirements for primary packaging materials. A CE certificate that names these standards provides documented evidence that a machine series has been assessed against them.

Market concentration is also relevant to supplier selection: one market intelligence report estimates that the top three players — Uhlmann, IMA and Marchesini — collectively hold approximately 29% of the pharmaceutical blister packaging machine market. The remaining share is served by manufacturers such as HOPING, which compete on integrated line design, documented certifications, and OEM/ODM customization capability.

Solution: what to verify in a CE certificate

A CE certificate is only as useful as its documentation. Four elements must be checked: the certificate number, the issuing authority, the applicable standard(s), and the scope of products covered. The certificate number makes the claim verifiable; the authority shows who performed the assessment; the standard shows what was tested; and the scope determines whether the target model is actually included.

Documented CE certificates at HOPING

• Blister packing machine series — CE certificate HTT190102306L, issued by Shenzhen HTT Technology Co., Ltd., tested and found compliant with the Machinery Directive 2006/42/EC and EN 60204-1:2006+A1:2009+AC:2010. Related products include the DPP Series and DPH Series blister packing machines, the DPP260T1 blister packaging machine, the DPH320HII blister machine and other models in the series.
• Cartoning machine series — CE certificate HTT190102307L, issued by Shenzhen HTT Technology Co., Ltd., in compliance with EN 60204-1:2006+A1:2009+AC:2010 and 2006/42/EC. Related products include the XWZ120, XWZ300II, XWZ Series and XWZ500H cartoning machines.
• Carton packing machine series — CE certificate UCN 900339024607, issued by Certify International Ltd, historical certificate evidence under EN 415-3:2000; 98/37/EC; 98/79/EC.
• Freeze-dried powder blister machine — CE certificate UCN 900175009261, issued by CELAB, historical certificate evidence under EN 60204-1:1997; EN 415-3:1999.

GMP-oriented materials and design

Machines designed for pharmaceutical use are not judged by certification alone. HOPING blister packaging machines such as the DPP260T1 and DPH320HII are designed and manufactured in accordance with GMP requirements. Product-contact parts are made of AISI 316L stainless steel and FDA-compliant pharmaceutical-grade materials; non-product-contact parts are manufactured from AISI 304 stainless steel and anodized aluminum alloy. The resulting surfaces are corrosion-resistant and easy to clean.

Integrated line designs follow the same principle. The DHL8005H (model designation DHL8005H) is a GMP-oriented line built from stainless steel and aluminum-alloy, with product-contact parts and tooling customized according to technical agreement, and includes mold-change and preset-memory functions.

Key parameters of CE-certified pharmaceutical packaging machines

The parameters below are published model specifications from the HOPING product range. They allow a buyer to match machine capacity, format area, utility requirements and footprint against a production target.

Blister packaging machines

Cartoning machines

Integrated blister-cartoning lines

Step-by-step: verify and specify a CE-certified machine

1. Request the CE certificate by number. Ask for the certificate number, issuing authority, applicable standard and issue date. Example: HTT190102306L for the blister packing machine series, issued by Shenzhen HTT Technology Co., Ltd.
2. Confirm the scope covers the quoted model. The certificate must list the series or model you are buying. For instance, the cartoning machine series certificate HTT190102307L relates to XWZ120, XWZ300II, XWZ Series and XWZ500H.
3. Check GMP-oriented design and materials. Verify that product-contact parts use AISI 316L stainless steel and FDA-compliant pharmaceutical-grade materials, and that non-contact parts use AISI 304 stainless steel and anodized aluminum alloy.
4. Match parameters to the production target. Compare capacity (blisters/min and cartons/min), format area, feed stroke, power supply, compressed air pressure and overall dimensions against your line layout and utilities.
5. Plan the full line configuration. HOPING supplies upstream and downstream modules: the LF100 lifting feeder, blister packing machines (DPP/DPH series), cartoning machines (XWZ series), flow wrappers (XW8200/XW8300), the XWK4060 stretch bander, XWK series case packers, and the ICP12 case packing and palletizing integral machine.
6. Confirm lead time, MOQ and after-sales. MOQ is 1 set or 1 complete line. Typical lead time is 60–120 days after technical confirmation. Quality control covers incoming material inspection, no-load trial runs, material trials, FAT, customer witness acceptance and pre-shipment inspection.

Use cases for CE-certified HOPING pharmaceutical packaging machines

• Tablet and capsule blister packaging. DPP260T1 (300 blisters/min) or DPH320HII (1000 blisters/min) for Alu-PVC and Alu-Alu formats in pharmaceutical, nutraceutical and healthcare applications.
• Blister-to-carton linked line. DPP Series + XWZ Series: typical blister capacity of 100–600 blisters/min and cartoning capacity of 100–400 cartons/min.
• High-speed solid dosage expansion. DHL7005H integrated line: up to 700 blisters/min and 500 cartons/min, with optional downstream bundling, case packing and palletizing.
• Moisture-sensitive or flow-wrapped products. IXW600 line: 600 blisters/min, 300 packs/min and 300 cartons/min; IXW800 line: 600 blisters/min, 600 packs/min and 500 cartons/min.
• Vial and injectable products. Automatic Vials Packing-Cartoning Production Line configured as Labeling + DPP + XWZ + XWK Series modules.
• Liquid dosage formats. IXW400 line for filled syringes, ampoules and cartridges: up to 400 blisters/min and 150 cartons/min.
• End-of-line secondary packaging. XWZ300II + XWK4060 + ICP12 production line: 60–220 cartons/min, 30–60 bundles/min and about 12 cases/min.

FAQ

What does CE certification cover on HOPING pharmaceutical packaging machines?

CE certification documents that a machine series has been assessed against applicable European directives and can use CE marking. HOPING's blister packing machine series is covered by CE certificate HTT190102306L, issued by Shenzhen HTT Technology Co., Ltd., in compliance with the Machinery Directive 2006/42/EC and EN 60204-1:2006+A1:2009+AC:2010. The cartoning machine series is covered by CE certificate HTT190102307L (same authority; standards EN 60204-1:2006+A1:2009+AC:2010 and 2006/42/EC). The carton packing machine series is covered by CE certificate UCN 900339024607, issued by Certify International Ltd, under EN 415-3:2000. The freeze-dried powder blister machine is covered by CE certificate UCN 900175009261, issued by CELAB, under EN 60204-1:1997. Buyers should request the certificate number and confirm the standard and scope in writing.

Which HOPING pharmaceutical packaging machines are CE certified?

The CE-certified series include the blister packing machine series (DPP Series, DPH Series, DPP260T1 platen blister packaging machine, DPH320HII rotary blister machine and related models), the cartoning machine series (XWZ120, XWZ300II, XWZ Series and XWZ500H), the carton packing machine series, and the freeze-dried powder blister machine (DP Series). HOPING's management systems for design, production and after-sales service of packing machines and packing production lines are certified to ISO 14001:2015 (CN00123E33896R1M/3300) and ISO 45001:2018 (CN00123S33121R1M/3300) by China Quality Certification Centre (CQC).

What are the key parameters of HOPING CE-certified blister packaging machines?

The DPP260T1 is a platen blister packaging machine with a maximum capacity of 300 blisters/min, a maximum format area of 260 x 115 mm, a feed stroke of 30–120 mm, a maximum punch frequency of 60 punches/min, a total power of 8.5 kW, overall dimensions of 4420 x 710 x 1700 mm and a net weight of 2200 kg. The DPH320HII is a rotary blister packing machine with a maximum capacity of 1000 blisters/min, a maximum format area of 320 x 280 mm, a feed stroke of 100–280 mm, a maximum punch frequency of 250 punches/min, a total power of 30 kW, overall dimensions of 5000 x 1500 x 2100 mm and a net weight of 6000 kg. Both are designed in accordance with GMP requirements, with product-contact parts in AISI 316L stainless steel and FDA-compliant pharmaceutical-grade materials.

Integrated blister-cartoning line or standalone machines: which should I choose?

An integrated blister-cartoning line links blister forming/sealing, product feeding, blister transfer, leaflet folding, carton opening, insertion, coding/inspection and downstream connection under synchronized servo control. HOPING's DHL series covers from 600 to 1000 blisters/min with 400 to 500 cartons/min (DHL6004, DHL7004, DHL7005H, DHL8005H and DHL1000/5H). A standalone combination such as the DPP Series + XWZ Series linked line targets 100–600 blisters/min and 100–400 cartons/min. Integrated lines reduce manual transfer and centralize control; standalone machines provide more configuration flexibility for lower speeds and frequent format changes.

What is the lead time and MOQ for a customized CE-certified pharmaceutical packaging line?

The MOQ is 1 set or 1 complete line. Typical lead time is 60–120 days after technical confirmation; the final lead time depends on model, configuration, project complexity and contract terms. HOPING's monthly production capacity is 30–40 units. Customization covers blister size, carton specification, leaflet format, coding/inspection method, feeding method, downstream bundling/case-packing/palletizing connection, interface language, electrical component brand and data interface. Quality control includes incoming material inspection, assembly inspection, electrical safety checks, no-load trial runs, material trials, FAT, customer witness acceptance and pre-shipment inspection.

How can I request a quote for a CE-certified pharmaceutical packaging machine?

Send your product and packaging data — dosage form, tablet or capsule dimensions, blister layout, carton size, leaflet format, target speed and utility conditions — to start technical confirmation. Contact Monica at monica@xwbj.com or +86 133-5610-5292 (phone/WhatsApp). HOPING is located at 88th Weiwu Road, Nanbin Sub-district, Ruian City, Zhejiang Province, China. The company catalog is publicly available at Hoping Machinery Catalog.pdf, and the official website is www.hopingcn.com. A quotation is issued after technical confirmation defines the line configuration.

Request the HOPING catalog or a line quotation.
Email: monica@xwbj.com | Tel/WhatsApp: +86 133-5610-5292
Zhejiang Hoping Machinery Co., Ltd. — 88th Weiwu Road, Nanbin Sub-district, Ruian City, Zhejiang Province, China
Download the company catalog (PDF)

Conclusion

CE certification is a documented, verifiable property of a pharmaceutical packaging machine series — not a marketing label. HOPING supports its range with named certificates, standards and issuing authorities: HTT190102306L for the blister packing machine series, HTT190102307L for the cartoning machine series, UCN 900339024607 for the carton packing machine series and UCN 900175009261 for the freeze-dried powder blister machine. When combined with GMP-oriented design, AISI 316L product-contact materials and published model parameters, these certificates give a procurement team the evidence needed to move from research to evaluation — and from evaluation to a technical confirmation with defined lead time, MOQ and line scope.