Pharmaceutical & Medicine Bottle ISBM Blow Molding Machine

One-step ISBM blow molding machine for pharmaceutical and medicine bottles, supporting medical-grade PET and PP with 2–6 cavities and output up to 7,200 BPH

توضیحات

ISBM Single-Stage
Medical-Grade PET / PP
GMP Compatible
9 Model Configurations

Pharmaceutical Bottle Production · 500 ml – 1,500 ml · 2 to 6 Cavities

Medicine Bottle Series
Blow Molding Machine

Nine models covering 2- to 6-cavity pharmaceutical bottle production. Neck diameters from 18–38 mm to 98 mm, output up to 7,200 bph. Medical-grade PET and PP, closed single-stage ISBM process — built for GMP-compatible pharmaceutical packaging environments.

7,200

BPH Max Output

9

Model Configs

±1°C

Temp. Control Accuracy

40%

Energy vs 2-Stage

Medicine Bottle Series ISBM Blow Molding Machine

Why Pharmaceutical Bottle Production Needs a Different Machine — Not Just Any ISBM Setup

Look, most ISBM machines are sold on output numbers — bottles per hour, cavities, max volume. That’s fine for water bottles and cosmetic containers. But for pharmaceutical packaging, the spec sheet questions that actually matter are a bit different: Can it hold ±1°C temperature control? Does the closed-mold cycle keep the interior surface of the bottle contamination-free without a secondary cleaning step? Does the neck finish accuracy meet the tolerances your child-resistant cap supplier specifies?

This series is purpose-configured for pharmaceutical bottle production — tablet bottles, liquid medication bottles, vitamin supplement containers, oral rehydration solution bottles, vitamin and supplement pill jars, and clinical reagent bottles. The nine models cover 2 to 6 cavities, output from 1,800 bph (2-cavity specialty) to 7,200 bph (6-cavity high-volume), and container volumes from 500 ml to 1,500 ml.

The single-stage ISBM process keeps the container’s inner surface in a closed environment from preform injection through to finished bottle ejection — no intermediate storage, no second-stage reheat, no handling between production steps. In pharmaceutical GMP terms, that means fewer contamination risk points to validate and document.

Regulatory Context

Pharmaceutical primary packaging (direct drug contact) must meet:

  • FDA 21 CFR 211 (cGMP for finished pharmaceuticals)
  • EU GMP Annex 1 (sterile medicinal products)
  • ISO 15378 (primary packaging materials for medicinal products)
  • ICH Q3D (elemental impurity guidelines for container leaching)

The ISBM closed-single-stage process directly addresses contamination control requirements under all four frameworks.

Pharmaceutical bottles produced by medicine bottle series ISBM machine

Complete Technical Specifications — All 9 Medicine Bottle Models

HGA.AS-2C114.3 · HGA.AS-4C76.2 · HGA.ES-2C100 · HGA.ES-2C114.3 · HGA.ES-2C130 · HGA.ES-3C76 · HGA.ES-4C76 · HGA.ES-4C100 · HGA.ES-6C76

Parameter Unit AS-2C114.3 AS-4C76.2 ES-2C100 ES-2C114.3 ES-2C130 ES-3C76 ES-4C76 ES-4C100 ES-6C76
MOLDING GROUP
Clamping Stroke mm 122 100 110 132 160 100 100 128 100
Mold-Open Distance mm 302 280 280 312 360 300 300 328 300
Mold-Close Distance mm 180 180 170 180 200 200 200 200 200
Stretching Stroke mm 400 350 350 400 350 240 350 350 350
Bottle Mold-Close Dist. mm 114.3 76.2 100 114.3 130 76 76 100 76
Preform Holder 48 96 60 60 60 72 96 92 130
Cavities 2 4 2 2 2 3 4 4 6
Container Specifications
Max. Container Volume ml 1,000 500 500 1,000 1,500 700 700 800 700
Max. Neck Diameter mm 88 48 68 88 98 18–38 48 68 38
Max. Container Diameter mm 94 65 80 94 110 68 68 80 68
Max. Container Height mm 260 250 200 260 250 240 240 250 240
Theoretical Output bph 2,000 4,000 2,400 2,000 1,800 3,000 4,800 4,600 7,200
Electrical System
Max. Heating Power kW 45 33 34 50 42.5 40 40 62.5 62.5
Normal Heating Power kW 20 17 8–12 16 8–13 18 18 21 26
Air System
Operating Pressure kg/cm² 7 (all models)
Blowing Pressure kg/cm² 35 35 26–35 35 26–35 35 35 35 35
High-Pressure Air ltr/min 1,600 4,000 1,000–1,400 1,000 1,000–1,500 2,400 3,900 4,000 5,800
Cooling Water
Operating Pressure kg/cm² 6 5–6 5–6 6 5–6 5–6 5–6 5–6 5–6
Temperature °C 8–12 8–10 8–10 8–12 8–10 8–12 8–12 8–12 8–12
Flow Rate ltr/min 30 40 30 30 30 30 30 30 40
Machine Dimensions
Size (L×W×H) mm 2660×1660×2150 3370×1850×2100 2900×1525×1930 3220×1660×2010 3600×1800×1980 2850×1850×2180 3290×1850×2260 4170×1930×2340 4690×2000×2000
وزن دستگاه kg 2,600 4,000 2,000 3,000 3,000 3,500 3,500 4,000 5,500

Low-pressure air: 600–900 ltr/min across series · All models 7 kg/cm² operating air pressure

Five Things That Separate a Pharmaceutical Bottle Blow Molding Machine from a General-Purpose ISBM Setup

GMP-compatible pharmaceutical bottle ISBM machine · medicine bottle production · tablet bottle blow molding machine · oral liquid container production · sterile pharmaceutical packaging equipment

CRITICAL

01

Closed-Cycle Contamination Control — the Biggest Difference from Two-Stage

In a two-stage SBM process, preforms are exposed to the factory environment during storage and handling between injection and blow stages. For food containers, that’s manageable. For pharmaceutical primary packaging, every exposure is a contamination risk that needs to be validated and documented in your GMP quality system. The single-stage ISBM cycle eliminates that intermediate exposure — from PET granule to finished medicine bottle, the internal surface of the container is never exposed to uncontrolled air. That’s the foundational pharmaceutical compliance advantage of ISBM, and it’s why regulatory frameworks like EU GMP Annex 1 and FDA 21 CFR 211 favour closed-process manufacturing.

02

Neck Finish Tolerance — the Spec That Determines Child-Resistant Cap Compatibility

Pharmaceutical bottles need neck finishes accurate enough to work reliably with child-resistant closures (CRCs) and tamper-evident caps. These closure systems are tested to ASTM D3475 (US) or ISO 8317 (international) standards, and the thread profile, OD, and finish diameter of the bottle neck must stay within tight tolerances for the cap to function as designed. ISBM produces neck dimensions by injection molding — not blow molding — so the neck geometry comes out of an injection mold with tolerances typically better than ±0.2 mm. That’s what CRC cap suppliers specify. EBM can’t reliably hit those tolerances on medical-grade applications.

03

6-Cavity ES-6C76 at 7,200 BPH — the High-Volume Option for Generic Drug Manufacturers

The HGA.ES-6C76 runs 6 cavities at up to 7,200 bottles per hour on containers up to 700 ml — that’s competitive with two-stage high-speed SBM lines for small pharmaceutical bottle formats (30–500 ml tablet bottles, cough syrup bottles, vitamin supplement containers). At 62.5 kW installed power and 26 kW normal operating power, the per-bottle energy consumption is significantly lower than a two-stage line of equivalent throughput. For generic drug manufacturers who need high-volume pill bottle production with GMP documentation traceability, this is the spec to look at.

04

Medical-Grade PP Option for Chemical-Resistant Liquid Medication Bottles

PET handles most tablet and dry-fill pharmaceutical bottles well — it’s clear, lightweight, and carries good moisture barrier properties. But liquid medications, particularly solutions containing ethanol, strong acids, or oil-based formulations, can interact with PET in ways that affect leachables compliance. Medical-grade PP (polypropylene) has broader chemical compatibility across pharmaceutical formulations and is the preferred material for oral suspension bottles, syrup bottles, and certain topical medication containers. The machine series runs both materials — material selection is a mold and process parameter decision, not a machine purchase decision.

05

Production Traceability — Because Pharma Regulators Will Ask About It

GMP requires batch records for primary packaging production. The machine’s control system logs key process parameters — injection temperature, blow pressure, cycle time, preform temperature — which can be exported and linked to your batch documentation system. This isn’t optional for pharmaceutical applications; it’s the baseline requirement for a supplier audit or FDA/MHRA inspection of your packaging manufacturing process. If your current bottle supplier can’t give you production parameter data for each batch, that’s a compliance gap. ISBM in-house gives you direct control over that data.

06

Biaxial Orientation Improves Clarity and Drop Resistance — Relevant for Child-Safe Dispensing

The stretch-blow process in ISBM biaxially orients the PET molecular chains during forming. This produces a bottle with 30–50% higher impact strength compared to non-oriented PET and significantly better optical clarity. For amber-tinted pharmaceutical bottles (UV-protection formulations), this means thinner wall sections are possible while maintaining structural integrity — reducing material cost per bottle. For clear pharmaceutical bottles on retail pharmacy shelves, it means the product clarity is closer to glass than anything EBM can produce.

What Pharmaceutical Containers Does This Machine Series Actually Produce?

tablet bottle blow molding machine · pharmaceutical liquid bottle production · vitamin supplement bottle ISBM · oral medication container manufacturing · clinical reagent bottle machine

Solid Dose / Tablet Bottles

Standard pharmacy tablet bottles (100 ml, 200 ml, 500 ml), child-resistant cap prescription bottles, vitamin and mineral supplement containers (60–1,000 tablet count), OTC pain relief packaging, veterinary tablet containers.

Liquid Medication Bottles

Cough syrup and antitussive bottles (100–500 ml, PP for alcohol-containing formulations), oral rehydration solution containers, paediatric liquid medication bottles, antacid suspension bottles, mouthwash and gargle bottles.

Nutraceuticals & Health Supplements

Omega-3 and fish oil soft gel capsule bottles (high-clarity PET), probiotic supplement containers (moisture barrier critical), protein powder single-serve containers, collagen and beauty supplement pill jars, sports nutrition bottles.

Clinical & Diagnostic

Reagent and diagnostic sample bottles (laboratory use, high clarity), specimen collection containers, disinfectant and antiseptic solution bottles, sterile saline containers (hospital and clinical use), contact lens solution bottles.

Veterinary Pharmaceuticals

Animal medication bottles (tablets and liquids), livestock supplement containers, veterinary antiseptic bottles, pet health supplement packaging — same GMP container standards apply in regulated veterinary markets.

Medicine bottle outputs from this machine series

Medicine bottle outputs from this machine series

The Questions Pharmaceutical Packaging Buyers Ask (and Straight Answers to Each)

medicine bottle blow molding machine buyer FAQ · GMP pharmaceutical ISBM machine questions · PET PP pharmaceutical bottle production guide

GMP Compliance

Is this machine GMP-certified? Will it pass an FDA or EMA inspection?

The machine itself is CE and ISO certified. GMP certification applies to a manufacturing facility and process — not to a machine in isolation. What we can tell you is: the closed single-stage ISBM cycle, combined with pharmaceutical-grade material use and process parameter logging, is fully compatible with the requirements of EU GMP, FDA 21 CFR 211, and ISO 15378. Whether your facility passes inspection depends on your entire quality system — SOPs, change control, batch records, environmental monitoring — not just the machine. We can provide the technical documentation needed for your Machine Qualification (IQ/OQ/PQ) process.

Material Safety

What grades of PET and PP are acceptable for direct drug contact, and can you supply material certificates?

For pharmaceutical primary packaging, you need PET or PP resin that meets USP Class VI or ISO 10993 biocompatibility standards, with Certificate of Analysis (CoA) and Drug Master File (DMF) support from the resin supplier. We don’t supply resin, but we can recommend resin grades from established suppliers (such as Eastman, BASF, LyondellBasell) whose pharma-grade materials have established regulatory track records. The resin selection decision is ultimately yours and your QA team’s — it’s not something the machine manufacturer can make on your behalf.

Child-Resistant Packaging

Can this machine produce bottles compatible with child-resistant closure (CRC) systems?

Yes — the injection-molded neck finish from ISBM is accurate enough to work with CRC caps. The key is mold design: your injection mold needs to produce the thread profile and finish diameter that your CRC cap supplier specifies (typically based on a standard neck finish like 28-400, 33-400, or a proprietary profile). We handle that in the mold design stage and can coordinate with your closure supplier to confirm compatibility before mold manufacturing starts. CRC testing to ASTM D3475 or ISO 8317 is done on finished bottles — we can supply samples for closure compatibility testing before production sign-off.

UV-Protected Bottles

Can the machine produce amber or coloured pharmaceutical bottles for light-sensitive medications?

Yes. UV-protective amber colouration is achieved by adding a pharma-grade amber masterbatch to the PET or PP resin. The masterbatch must comply with food/pharma contact regulations and be free from substances of concern (heavy metals, restricted colorants). Amber PET pharmaceutical bottles produced by ISBM typically achieve UV transmittance below 1% at 290–450 nm, which meets EP/USP requirements for Type III glass amber equivalent protection. The formulation of the masterbatch and testing against pharmacopoeia light-protection specs is something you do with your resin/masterbatch supplier — not with us.

Multi-SKU Production

We have 8 different tablet bottle formats. Can one machine handle all of them?

If your 8 formats fall within the volume and neck diameter range of a single model (e.g., all under 700 ml with 48 mm neck — handled by the ES-4C76), then yes, one machine with 8 mold sets covers them. Changeover time is 2–4 hours per mold set swap on a 4-cavity model. If your formats span a wide volume range (e.g., 100 ml to 1,500 ml), you might need two models to cover the full range without mold-parameter compromises. That’s a conversation worth having before you commit to a machine spec — send us your bottle list and we’ll map it to the right model configuration.

Cleanroom Integration

Can the machine be installed in a cleanroom or GMP production area?

The machine can operate in a controlled pharmaceutical production environment. Standard installation requires normal factory conditions (16–30°C ambient, standard 3-phase power, compressed air and chilled water utilities). For ISO 7 or ISO 8 cleanroom installation, the main considerations are: machine surface materials (304 stainless steel and anodised aluminium panels are standard), exhaust and particulate management (the machine generates some hydraulic heat and minimal particulate from mechanical components), and cleaning protocol compatibility. We can discuss cleanroom-specific installation requirements and any modifications needed during the project specification stage.

Medicine Bottle Series · ISBM Blow Molding Machine · 9 Configurations

Tell Us Your Bottle Specs, Volume Range, and GMP Requirements —
We’ll Recommend the Right Configuration and Send a Quote

Nine models, 2 to 6 cavities, up to 7,200 bph. Whether you’re setting up a new tablet bottle line, scaling up liquid medication production, or switching from a bought-in bottle supply to in-house manufacturing — let’s work through the numbers together.

9 Models

2 to 6 cavity options

GMP Compatible

IQ/OQ/PQ documentation

Custom Mold Design

CRC-compatible neck finishes

24h Response

Quote with full specs