我们为该行业提供的设备
无油涡旋空压机
安静、小巧、真正无油。7.5 至 37 kW，8 bar g。
- 容积流量（FAD）
- 0.8 – 4.0 m³/min
- 工作压力
- 8 bar g
- 电机功率
- 8 – 37 kW
水润滑无油空压机
用水代替油来密封和冷却转子。Class 0 空气，5.5 至 160 kW。
- 容积流量（FAD）
- 0.3 – 27.0 m³/min
- 工作压力
- 7 – 10 bar g
- 电机功率
- 6 – 160 kW
无热再生吸附式干燥机
不用加热器就做到 −40 °C 露点。结构简单、可靠，消耗再生气。
- 容积流量（FAD）
- 1.4 – 80.0 m³/min
制氮机
在自己厂内制氮，不必再买瓶装气和付运费。
- 重量
- 45 – 1,850 kg
精密压缩空气过滤器
颗粒、聚结与活性炭，按您工艺所需的空气品质分级配置。
- 容积流量（FAD）
- 1.8 – 80.0 m³/min
制氧设备
用自己的空气做 PSA 与 VPSA 制氧，纯度 90 至 95%。
- 工作压力
- 4 – 5 bar g
干式螺杆真空泵
深度干式真空，能承受蒸汽与工艺夹带物。
- 工作压力
- 0 – 20 bar g
- 电机功率
- 4 – 63 kW
- 重量
- 250 – 2,750 kg
储气罐与储罐
0.3 至 6 m³，碳钢罐与真空罐。8、10 与 13 bar g。
- 工作压力
- 1 – 13 bar g
- 重量
- 99 – 1,240 kg
概述
In a regulated pharmaceutical facility, the compressed air system is qualified equipment. Design qualification, installation qualification, operational qualification and performance qualification all apply, and the documentation package is as much of the deliverable as the machinery.
We supply the equipment together with the qualification protocols, calibration certificates, material certificates and change control documentation your quality department will require.
主要优势
Full qualification package
DQ, IQ, OQ and PQ protocols supplied and executed with the installation.
Continuous monitoring
Dew point, particulate and oil content monitored and alarmed, with data retention.
Redundancy built in
N+1 configuration so a single machine failure never stops a batch.
Change control aware
Any modification documented in a form your QA system can accept.
What the process needs
Oil free air, certified rather than assumed, and a documented path from the compressor to the point of use. In this industry the documentation is part of the product.
Dew point is specified and measured, not indicated. A desiccant dryer with dew point dependent switching and a measured reading is the normal arrangement.
Redundancy is usually a requirement rather than a preference. A batch lost to an air failure costs more than the standby machine did.
- Certified oil free air, ISO 8573-1 Class 0
- Dew point specified and measured
- Documented path to the point of use
- Redundancy designed in
- Sterile filtration at point of use
- Materials and finishes specified
- 提供验证文件
- Change control supported
Validation and records
We supply the documentation a validation needs rather than leaving it to be assembled afterwards. Certificates, specifications, calibration records and the service history.
Any work that could affect the air path is recorded and the certification is reissued, because an auditor asks what has happened since the last one.
Change control is respected. We do not alter a setting on a validated system without the paperwork, however small the change looks.
- 提供验证文件
- Certification reissued after any works
- Calibration records kept and issued
- Change control respected on every visit
- Engineers briefed on GMP expectations
- 按序列号保存记录
- Copies issued for the quality system
- Support during inspection
How we support a site
Planned work only, scheduled around your production windows, with rental cover where a machine has to come out.
Redundant plant serviced in rotation so there is never a window with no standby available.
And an honest view on specification. Over specifying costs energy every hour, and under specifying costs a batch, so the class is chosen against the actual contact.
- Planned work in your production windows
- Rental cover during any removal
- Redundant plant serviced in rotation
- Specification matched to actual contact
- Priority response on a plan
- Local engineers in every market we serve
- Spares holding agreed for critical items
- Annual review of the whole system
常见问题
Is the compressed air system qualified equipment?
Yes. In a regulated facility DQ, IQ, OQ and PQ all apply, and the documentation package is as much of the deliverable as the machinery.
What documentation do you provide?
Qualification protocols executed with the installation, calibration certificates, material certificates and change control documentation your quality department can accept.
What monitoring is expected?
Continuous dew point, particulate and oil content with alarms and data retention. Spot checks are not enough for a regulated utility.
Do I need redundancy?
Normally N+1, so a single machine failure never stops a batch. On a product with a long cycle time the cost of an interruption makes this an easy decision.
What air quality class applies?
It depends on the process step, but 1.2.1 or better is common for anything reaching product or primary packaging. We specify against your own user requirement specification.
Does a change to the compressor need change control?
Yes, and we document any modification in a form your QA system can accept, including like-for-like part substitutions where they affect the qualified state.
Oil-free or filtered oil-injected?
Oil-free. In a regulated environment the argument is not about typical performance but about what happens when a filter fails, and with no oil there is nothing to fail.
How do you handle validation of the dryer?
Dew point performance is demonstrated across the operating range and recorded, not assumed from the nameplate. That record goes into the validation file.
Can you support a regulatory inspection?
Yes, we keep the installation and service history and can provide the records and personnel to support an inspection at short notice.
What about cleanroom utilities?
Air quality, pressure stability and low particulate all matter. We size and specify for the cleanroom classification rather than the general plant standard.
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