Internal Audit For Environmental Clean Room Requirements

Internal Audit For Environmental Clean Room Requirements

Internal Audit Of Environmental

Environmental auditing is a management tool used to evaluate how well a company or industry performs its environmental management activities while also educating them on newer, cleaner technology.

Due to the impact of industry sectors and their products on natural resources and environmental quality, environmental auditing is required to ensure the growth of environmentally responsible industry sectors.

What Is A Clean Room?

Introduction Cleanrooms are a technological solution to contamination control in pharmaceutical manufacturing and healthcare operations. Cleanrooms are intended to protect products, personnel, and equipment from contamination by creating clean and controlled environments. Cleanrooms are also used in other industries such as microelectronics, semiconductor manufacturing, and optical applications. the evolution of cleanrooms and describe significant historical milestones, from the eighteenth-century concept of a “clean space” to the twenty-first-century cleanroom.

Types Of Clean Room

  • GMP clean room(drugs)

  • ISO clean room (MEDICAL DEVICE)

Types Of Contamination

  • Particulate- Dust ,skin ,hair ,makeup

  • Chemical- oil , grease, metal ,perfume

  • Biological- Bacteria ,fungai , rodent

  • Radiation- Ultraviolet , light

Why Should Need Clean Room

  • Biotechnology

  • Pharmaceutical

  • Nanotechnology

  • Food & drink

  • Electronics

Clean Room Classification

  • ISO-14644-1

  • Federal Standard 209

  • GMP


According to the quantity and size of the particles per cubic metre of air, cleanrooms are categorised based on how clean the air is. Although there are numerous classifications, there is a growing trend to switch from earlier classification systems to the ISO classification system in ISO 14644-1.

This ISO standard includes these cleanroom classes: ISO 1, ISO 2, ISO 3, ISO 4, ISO 5, ISO 6, ISO 7, ISO 8, and ISO 9. ISO 1 is the “cleanest” class ISO 9 is the “dirtiest” class. as the “dirtiest” class, the ISO 9 clean room environment is more than a cleanroom.

What Are The Clean Room Classifications?

The ISO 14644-1 has changed these numbers to simple classes:

ISO 14644-1 Cleanroom standards-

Particulate concentration in cleanrooms changes over time, from equipment construction and installation to operational status. ISO classifies cleanrooms into three categories: as-built, at-rest, and operational. An “as-built” cleanroom becomes an “at-rest” cleanroom as instruments and equipment are introduced and particulates rise. When people are added to the matrix, particulate levels in the “operational” cleanroom rise even further.

Federal Standard 209E (US FDA)

The USA FD 209 was released by the Institute of Environmental Science and Technology (IEST). In 1963, the General Service Administration of the United States granted FS 209 approval, making it a required organisation to perform work for the United States government.This document’s standard classes define the air cleanliness of clean rooms and zones based on a particular concentration of airborne particles.The suggested technique for verifying air cleanliness required the creation of a plan and the observation of air quality.Many companies use the outdated class 100, class 10,000, and class 100,000 terminology despite the new federal standard 209 classifications (class 100, class 10,000, and class 100,000) being introduced in 1999 and revised in 2015.

US. Federal Standard 209E Cleanroom Standard

Particulate concentration in cleanrooms changes over time, from equipment construction and installation to operational status. ISO classifies cleanrooms into three categories: as-built, at-rest, and operational. An “as-built” cleanroom becomes an “at-rest” cleanroom as instruments and equipment are introduced and particulates rise. When people are added to the matrix, particulate levels in the “operational” cleanroom rise even further.

Medical Device Cleanroom Requirements?

What Cleanroom Classification is Required for Class I, Class II, and Class III Devices?

Our cleanroom teams frequently advise on both large and small operations. Many of our customers want to know if a Class I or Class II device or a specific technology requires an ISO Classification. Some companies only want to make a specific area cleaner or layout manufacturing cells that separate cleaner tasks from dirtier ones; they don’t need standardised compliance.

Class I and ClassII medical devices commonly operate in ISO 7- or ISO 8 cleanrooms. A softwall cleanroom is frequently used in place of a dedicated installation because a Class 1 device is exempt from the requirement for a Quality Management System. Class III devices require the strictest manufacturing regulations because they are more risky and subject to more regulation. Particles become more of a problem as device complexity and part sizes increase. This causes many facilities to classify more thoroughly than is actually necessary to future-proof the construction for changing process requirements.

Class 2 – 3 Medical Device Cleanrooms

This post classifies cleanroom design parameters during medical device manufacturing. Establishing criteria is a challenge. The FDA does not set forth any cleanroom classification or particulate level based on application.

Medical Devices Required Cleanroom Production

All invasive procedures involve making contact between a surgical tool or medical device and the sterile tissue or mucous membranes of the patient. The introduction of pathogenic microbes that could cause infection is a significant risk associated with all such procedures. If the sterile barrier is breached, failing to properly disinfect or sterilise new or reusable medical equipment or device poses a dangerous risk. Environmental controls are based on the intended use of an object: critical items, such as surgical instruments or implantable devices, are those that come into contact with sterile tissues. Mucous membranes, endoscopes in the medical field, and even drill guides for dental work are semicritical items. Stethoscopes and other noncritical items are those that only come into contact with the skin. These categories, which include high-level disinfection and low-level disinfection, each designate a particular threshold of sterilisation and disinfection.

ISO 14644 – FS-209E Medical Device Cleanrooms

He authoritative documents ISO 14644 and FS-209E don’t give any specific guidelines for actions to be taken in environments housing medical devices.

In general, medical device manufacturing takes place in ISO 5 to 8 cleanrooms (Class 100 – 100,000).

Packaging for medical devices is done in an ISO Class 7–8 cleanroom. A designated growing room and occasionally softwall environments in packaging or preparation areas are included in an ISO 8 environment.

Specific performance criteria are needed for the classification of sterile barriers, isolators, and surrounding environments.

Cleanroom Principle

Cleanrooms maintain particulate-free air by using HEPA or ULPA filters with laminar or turbulent air flow principles. Air flow systems that are laminar, or unidirectional, direct filtered air downward in a constant stream. To maintain constant, unidirectional flow, laminar air flow systems are typically installed across the whole roof.

GMP (Good manufacturing practice)

The EU GMP guidelines are more severe than others, requiring cleanrooms to meet particle counts both during operation (during the manufacturing process) and at rest (when the production process is not being performed).

– Cleanroom test method

  • Source
  • Facilities
  • Tools
  • Fluids
  • The products beings manufacturings

Test Time Clean Room Frequency

Cleanroom Monitoring Latest

HEPA ( High Efficiency Particulate Air)

They are air filtration devices called box type depth filters. Glass fibres make up these filters. HEPA filters are 99.97% effective against particles that are 0.3 microns across.


1. Hot dop test
2. Cold dop test
3. Air flow resistance test

ULTRA Low Penetration Air (Ultra Low Penetration Air)

Almost all ultrafilters are easy to replace extensive media dry filters with a minimum particle collection efficacy of 99.9997% for particles larger than or equal to 0.12 microns in size.

Grade Definitions For The Manufacture Of Sterile Medicinal Products

There are four grades or levels of manufacturing required when manufacturing sterile medicinal products clean room:

Grade A – It specifies the local zone for high-risk operations like filling zones, stopper bowls, open ampoules and vials, aseptic connections, and ampoules and vials that are not closed. Typically, a laminar airflow workstation provides these conditions. The working position’s homogeneous air speed in a laminar flow system is 0.45 m/s +/- 20%.
Grade B – This creates the environment necessary for grade A zone items that require aseptic preparation and filling.
Grade C and D – Tasks that are completed in less crucial stages of the manufacturing process are carried out in areas designated as grades C and D.