Upgrades Needed for Pharma‑Level Cleanroom

Upgrades Needed for Pharma‑Level Cleanroom

1. Air Handling & Filtration

• More robust HVAC → You’d need higher air change rates:
  • ISO 7: ~60+ air changes per hour.
  • ISO 6: ~90–180 air changes per hour (lots of airflow!).
• Additional HEPA (or ULPA) filters at terminal vents.
• Strict laminar airflow → Smooth, unidirectional air flowing top‑to‑bottom or side‑to‑side, not random swirls.
• Continuous pressure monitoring → Differential pressure gauges with active alarms if the cleanroom loses positive pressure.

2. Environmental Monitoring

• Pharma environments require continuous monitoring of:
  • Particle counts (real‑time laser particle counters).
  • Microbial contamination (settle plates, surface swabs, air samplers).
  • Temperature and humidity.
• All this data must be recorded and auditable. For mushrooms, you care about spores too, but you don’t log data to satisfy regulators.

3. Entry & Gowning Protocols

• ISO 7–8 mushroom room: basic clean coveralls, gloves, hairnets = good.
• Pharma ISO 6–7: multi‑stage gowning.
  • Separate entry airlocks (personnel and materials).
  • Garments: full sterile gowns, sterile gloves (double‑gloving), boot covers, sometimes masks and goggles/hoods.
• Air showers at entry points are common.

4. Materials & Surfaces

• Mushrooms: smooth, sealed, cleanable is fine.
• Pharma: everything must be validated as non‑shedding, non‑porous, chemical‑resistant.
• Often seamless epoxy flooring → no cracks allowed.
• Corners are coved (rounded), not sharp, so nothing collects.

5. Cleaning & Validation Protocols

• Mushrooms: regular sanitization with alcohol, bleach, peroxide fogging.
• Pharma: cleaning must be validated and documented. Every cleaning agent has a written SOP (standard operating procedure). Staff are trained, checklists are signed, logs are kept… basically, mushrooms don’t care about paperwork, but regulators do.

6. Documentation & Compliance

• Pharma = GMP (Good Manufacturing Practices).
  • Every procedure, from changing filters to mopping floors, has a written SOP.
  • Deviations must be written up and signed off.
  • Environmental monitoring results are archived.

Shenzhen ZhongJian South Environment Co., Ltd was founded in 2003.

Which is the only high-tech technology company in Southern China with CNAS certification

We are mainly engaged in Designing Manufacturing, Testing & Verification, Manufacturing Processes and Quality Control, Engineering & Installation and After-Sale Service of clean room and devotes to control and treatment of air PM2.5, formaldehyde, benzene, VOC and other toxic and hazardous substances.

Our main clean room products and equipment include air filter, air shower/cargo shower room, high efficiency air outlet, FFU, AMC chemical filter.

We serve chip microelectronics, data centers, chemical laboratories, new energy, medical devices, pharmaceutical manufacturing, food and beverage, cosmetics, biotechnology, precision instruments, aerospace and other industries. The business fields involve clean room products and equipment, air micro-pollution services, clean design and installation, including household fields, commercial fields, industrial fields and animal husbandry fields.

We won good reputation in this industry. Products and services are highly acknowledged and recommended by customers, we hold strong influence and competitiveness in the market as well. With the mission of being the leading enterprise in Control and Treatment of Air Micro-Pollution, We strive for the leapfrog development of products, technologies and services in Spirit of The Pioneering, Innovative, Combatant and Progressive. We would constantly bring forth new ideas in the innovation and development with protection and sustainable China's environment.