Clean Booths and Automatic Roll Air Filters in the Pharmaceutical Industry

Clean Booths and Automatic Roll Air Filters in the Pharmaceutical Industry

In the pharmaceutical sector, clean booths have become an increasingly popular alternative to full-scale cleanrooms, offering localized contamination control at a fraction of the cost. For manufacturers in Europe and North America, compliance with GMP (Good Manufacturing Practice) standards is the key driver shaping equipment design. To meet these requirements, companies are now pairing modular clean booth structures with HICLOVER Automatic Roll Air Filter systems, ensuring reliable prefiltration and reduced maintenance.

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GMP Requirements and Air Quality

Under EU GMP Annex 1 and FDA cGMP guidelines, pharmaceutical production areas must maintain controlled levels of particulate and microbial contamination. Clean zones are typically classified according to ISO 14644-1 standards, ranging from ISO Class 5 (critical aseptic processing) to ISO Class 8 (support areas).

• Clean booths are often deployed in ISO Class 7–8 zones, where they provide localized clean air environments around filling lines, weighing stations, or packaging areas.

• Automatic roll filters act as prefilters upstream of HEPA systems, keeping particle concentrations within GMP limits while extending HEPA lifespan.

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Why Automatic Roll Air Filters Add Value

The HICLOVER Automatic Roll Air Filter integrates seamlessly into pharmaceutical cleanroom HVAC systems. Its advantages for GMP compliance include:

1. Automated Media Replacement – PLC-controlled advancement ensures consistent airflow without manual intervention, a major benefit for facilities operating 24/7.

2. Stable Pressure Differentials – Maintaining low resistance avoids fluctuations that could compromise airflow velocity in critical operations.

3. Reduced Contamination Risk – Eliminates frequent manual filter handling, which is often a vector for contamination.

4. Cost Efficiency – Extends HEPA service intervals, lowering both downtime and operational expenses.

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Market Applications in Europe and North America

• Europe: In EU-regulated facilities, clean booths with roll filter prefiltration are widely used in compounding pharmacies, biotech labs, and aseptic packaging zones, where ISO Class 7/8 conditions are sufficient.

• United States & Canada: Pharmaceutical manufacturers increasingly choose modular clean booths with automated filtration for R&D labs, clinical trial material production, and secondary packaging, as they balance compliance with flexibility.

By adopting HICLOVER’s roll filter technology, pharmaceutical clients can demonstrate GMP-aligned practices while optimizing lifecycle costs.

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Résumé en Français (SEO)

Dans l’industrie pharmaceutique, les clean booths combinés avec le filtre à air en rouleau automatique HICLOVER garantissent la conformité GMP. Ils maintiennent les normes ISO 14644, réduisent les coûts et prolongent la durée de vie des filtres HEPA.

Краткое описание по-русски (SEO)

В фармацевтической промышленности чистые кабины с автоматическим рулонным фильтром HICLOVER помогают соблюдать требования GMP, снижая затраты и обеспечивая стабильный воздушный поток.

Resumen en Español (SEO)

En el sector farmacéutico, los clean booths con el filtro de aire enrollable automático HICLOVER cumplen con GMP y mejoran la eficiencia energética al proteger los filtros HEPA y reducir el mantenimiento.

Resumen en Mexicano (LatAm SEO)

Para la industria farmacéutica en México y América Latina, los clean booths con HICLOVER filtro automático permiten cumplir GMP, asegurar aire limpio y reducir costos de operación.

한국어 요약 (SEO)

제약 산업에서 클린부스와 HICLOVER 자동 롤 에어 필터는 GMP 규정을 충족하며, HEPA 필터 수명을 연장하고 유지비를 절감합니다.

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在制药行业，洁净棚因其成本较低、灵活度高，已成为部分无尘车间的替代方案。对于欧美市场客户来说，最关键的指标是符合GMP（药品生产质量管理规范）。因此，越来越多企业将洁净棚与HICLOVER自动卷绕式空气过滤器结合使用，以实现稳定的预过滤效果并降低维护频率。

GMP要求与空气质量

根据欧盟GMP附录1与美国FDA cGMP规范，制药生产区域必须严格控制颗粒物与微生物污染。洁净区按照ISO 14644-1标准划分，从ISO 5级（无菌关键工序）到ISO 8级（辅助区域）。

• 洁净棚常用于ISO 7–8级区域，如称量区、灌装线或包装工位。

• 自动卷绕式过滤器作为HEPA前置过滤，有助于维持GMP要求的空气颗粒浓度，并延长HEPA使用寿命。

自动卷绕式过滤器的价值

HICLOVER卷绕式自动过滤器 可无缝集成至制药厂HVAC系统，主要优势包括：

1. 自动更换滤料：PLC智能控制，保证气流稳定，适合24小时连续运行。

2. 稳定压差：低阻力避免气流波动，确保关键工序气流速度不受影响。

3. 降低污染风险：减少人工频繁操作，降低人为污染源。

4. 成本效益：延长HEPA更换周期，减少停机和运行费用。

欧美市场应用

• 欧洲：在欧盟法规下，洁净棚结合卷绕式过滤器广泛应用于配药室、实验室、生物制药及包装区域。

• 美国与加拿大：制药企业倾向于采用模块化洁净棚与自动过滤组合，应用于研发实验室、临床试验物料生产、二次包装，既符合GMP又保持灵活性。

通过采用HICLOVER的卷绕式过滤技术，制药行业客户能兼顾法规合规与成本优化，在国际市场保持竞争力。

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