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EU GMP Annex 1: What It Means for Pharmaceutical Isolators

EU GMP Annex 1: What It Means for Pharmaceutical Isolators

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Autoclave Servicing

We support healthcare, pharmaceutical, and laboratory facilities with expert servicing for steam, low-temperature, and EO sterilisers. Our UKAS accredited team work in compliance with BS EN 285 and HTM 01-01 for healthcare, BS 2646 for laboratory, and cGMP for pharmaceutical autoclaves.

Planned Preventative Maintenance (PPM)

  • Minimal disruption to operations
  • Maximise equipment lifespan
  • Planned visits with precision
Schedule your maintenance

Non-Contractual Support

  • Ad-hoc servicing and repair support
  • Emergency assistance can be provided
  • Flexible call-out support, contract-free
Request support

Validation & Compliance Testing

  • Fully certified & traceable testing
  • All brands, all models covered
  • Reports via SychemEye portal
Book your validation

Autoclave Accreditations

UKAS-accredited

As a UKAS-accredited calibration provider for temperature-controlled autoclaves, media preparators, and sterilisers, we help ensure your autoclave consistently achieves the temperatures and conditions required for effective sterilisation, supporting validation, compliance, and audit requirements.

BS EN285 & BS 2646

We perform the testing and inspections required to support BS EN 285 and BS EN 2646 compliance, helping ensure your steriliser continues to operate safely, consistently, and effectively.

HTM 01-01 Compliant

Our testing, servicing, and documentation help healthcare facilities demonstrate compliance with HTM 01-01 while maintaining confidence in their sterilisation process.

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What sterilisers do we service?

Our expert engineers service and maintain all types and brands of autoclaves, including equipment from leading manufacturers such as Getinge, BMN Weston, and all machines by our trusted partner, SteelcoBelimed. Our engineers are trained to provide UKAS-accredited thermometric testing to help support compliance with HTM 01-01, BS EN 285 for healthcare, BS 2646 for laboratory, and cGMP for pharmaceutical autoclaves.

Steam sterilisers

Low-temperature sterilisers

EO sterilisers

Autoclave Servicing Explained

How often should a steriliser be serviced?

Most sterilisers should be serviced at least annually by a qualified engineer. However, service frequency depends on factors such as equipment type, usage levels, manufacturer recommendations, and compliance requirements. High-use sterilisers in pharmaceutical facilities and busy laboratory environments may require more frequent maintenance and inspections to maintain reliability and minimise downtime. NHS hospitals are required under HTM 01-01 to service sterilisers at least quarterly.
Read our blog about autoclaves

What are the steps of steriliser calibration?

Steriliser calibration verifies that temperature and pressure readings accurately reflect operating conditions. Qualified engineers compare sensors against certified reference instruments, make any necessary adjustments, verify performance, and issue certification to support compliance, validation and reliable sterilisation.
Learn more about sterilisation
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SychemEye is a cloud-based portal is improving the way you manage and monitor your equipment. Available to our servicing clients.

Request a servicing quote

Faster Access

Get instant access to your quarterly, biannual, and annual validation reports directly through SychemEye portal. Access essential information that supports compliance and audit-readiness.

Real-Time Management

Our SychemEye portal provides seamless access to your validation history, reports, and archived data.

Detailed Insights

View comprehensive equipment data for all your devices, allowing for quick, informed decisions and a proactive approach to maintenance and compliance.

FAQs

What is included in an autoclave service?

Autoclave servicing includes inspections, safety checks, performance testing, and preventative maintenance to ensure reliable operation and compliance.

What is the difference between validation and calibration?

Calibration checks and adjusts sensor accuracy, while validation confirms that the steriliser can consistently achieve effective sterilisation conditions.

What is HTM 01-01?

Calibration checks and adjusts sensor accuracy, while validation confirms that the steriliser can consistently achieve effective sterilisation conditions.

Do I need a service contract for support?

You do not need a service contract with Sychem to benefit from our expert support. Whether you need a one-off repair, technical assistance, routine servicing, or an emergency callout, our engineers are here to help. However, if you want the best value and a faster response time, a contract with us is the way to go.

Can autoclave service help prevent breakdowns?

Regular autoclave servicing helps reduce the risk of unexpected breakdowns by identifying potential issues before they become costly faults. Our tailored servicing plans help maximise equipment reliability, minimise downtime, and support ongoing compliance, ensuring your autoclave continues to perform efficiently.

Keeping Your Facility Operational with Leading Servicing Solutions.

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EMERGENCY SUPPORT

Out-of-Hours Technical Assistance

If you are experiencing an equipment emergency, don’t hesitate to call us immediately. Our out of hours number is manned until 5:30pm - 11:00pm on weekdays and 8:30am-5:30pm on weekends.

Out of Hours

02380 013531

During Office Hours

02380 240729