Bio-Pharma Industrial Clean Room Solutions----------Sampling Booth

SAMPLING BOOTH: MATERIAL OF CONSTRUCTION: SS 304 (1.2 MM) EXTERNAL DIMENSIONS Max (WXDXH):2000 X 2000 X 2350   MM       INTERNAL DIMENSIONS (WXDXH):1900 X 1500 X 2000MM      SPECIFICATION SAMPLING BOOTH Dispensing Booth / Sampling Booth designed to provide Class 100 working environment at rest with built in scavenging system to ensure Product, operator as well as surrounding environment Protection. CONSTRUCTION : SS 304 (0.8 MM) Except Filters and motor-blower assemblies which will be in standard execution. HEART OF SYSTEM COMPRISES OF Ø   Imported Minipleat HEPA Filter with hot melt technology, which conforms to EU 13 Grade, with an efficiency rating better than 99.99% for 0.3 μ at supply position. Ø   Imported Minipleat HEPA Filter with hot melt technology, which conforms to EU 13 Grade, with an efficiency rating better than 99.99% for 0.3 μ at exhaust position. Ø   Prefilter which conforms to EU 4 Grade, with efficiency of 90% down to 10 micron These Filters are basically made from micro-Fibre-glass media and are inherently washable. Ø   Intermediate filter which conforms to EU 7 Grade, with efficiency of 95% down to 3 micron. These Filters are basically made from micro-Fibre-glass media and are inherently washable. Ø   Motor Blower provided are statically and dynamically balanced, Supply of sufficient capacity and static pressure is used to take care of airflow requirement for entire life of HEPA. Blower is high performance, noise abated, light weighted statically and dynamically balanced. Ø   SS 304 Double Walled Side Panels. Ø   Dwyer Make Magnehelic Differential Pressure Gauge (0 – 25 mm: 2 Nos.) to monitor pressure drop across intermediate filter & HEPA filter and (0-10mm: 1No.)  To monitor pressure drop across PRE Filter with respect to ambient Ø   Electrical control panel mounted on the side panel of the unit. Ø   Fluorescent Light (250 Lux) Ø   ON/OFF Switches for motor & lights Ø   5/15 Amp single-phase switch socket for external equipment. Ø   DOP Test port at upstream of HEPA filter PERFOMANCE Ø   Air cleanliness         :          ISO Class 5  (ISO 14644-1:1999 (E) Ø   Air Velocities           :         0.45 ± 0.05 mps Ø   Air Flow                   :          Vertical - Recirculatory Ø   Noise Level              :     Less than 67 dB on Scale ‘A’ when Ambient is not greater than 55                                                                            dB on Scale ‘A’ Ø   Vibration Level        :      Minimum POWER SUPPLY  :    230 V AC   1-Ø 50HZ

GMP Clean Room and GMP Standards

GMP Clean Room and GMP Standards

GMP Introduction

GMP is the abbreviation of Good Manufacture Practice, is the reasonableness of the production process, the applicability of the production equipment, accuracy and normative of the production operations made ​​mandatory requirements. The latest edition of " Good Manufacturing Practice ( revised 2010 ) ‘’ was October 19, 2010 defined by the Health Ministry for consideration by hereby release , since March 1, 2011 came into effect.

GMP is the basic criteria for pharmaceutical production and quality management, is the key processes affected product quality in production of pharmaceutical preparations entire process and the manufacture of APIs. Vigorously promote drug GMP, in order to avoid possible contamination of pharmaceutical production processes and cross-contamination to reduce all kinds of errors occur, is an important measure to improve the quality of medicines .

At present, drugs produced in China sales in worldwide required manufacturers not only to comply with the of China 's version of 2010 GMP norms, but also in line with international EU / GMP standards, FDA-c GMP requirements.

GMP did not list the biological clean room design, construction, testing and other requirements. The details should refer to the relevant GMP implementation guide, drug GMP certification examination assessment standards, FED209E, ISO14644, ISO14698, IEST, international GB / T, EN1822 standards

Clean room and contamination control technology is one of the main means to ensure that GMP successful implementation.

Biological Clean Room Standards

Air Clean Class Level
Bio- clean room air clean area is divided into four areas:
Class A - high-risk operation area, which directly affects the operation area. Like sterilization tunnel oven, aseptic filling, bottle opening, autoclave cooling zones required 100 clean class laminar flow. Direct impact on the quality of products, called Class A.
Class B - indirect effects of the sterile operating area directly surrounding the class A area, like aseptic filling room, autoclave cooling room.
Class C and D - into the transition clean zone of the sterile production area. Preparation Room, changing rooms and a buffer room.

GMP RSP Grading in Different Standards Roughly Contrast

Prepared By: Vanessa Wang from Web: www.cleanroomffu.com

What is the difference between clean booth and modular clean room?

What is the difference between clean booth and modular clean room?

1. Clean booth
Clean booth, also known as clean shed / softwall clean room / ISO5 laminar flow clean booth /1000class ISO6 clean booth/ 10,000 modular clean room, transparent plastic sheeting to prevent static electricity in the chaotic stream of clean room space surrounded by a small space, using HEPA or ULPA and independence of air conditioning units and become a more senior of the clean room, the level of 100 to 10,000 , the interior space of about 2.0 meters in height, covering an area of ​​about 50m2 or less, four pillars can be installed wheels, for flexibility in the use, supporting Air shower use.

2. Clean booth material :
Framework clean booth generally three types: stainless steel square pass, iron square pass, aluminum.
Clean the top shelf material generally three types: stainless steel, cold rolled steel spray , anti -static power grid around the curtain , (anti-static ) acrylic sheet .
Clean air section , the general choice FFU laminar flow hood (FFU laminar flow air supply unit )
Clean booth envelope materials generally include : anti-static curtain around , (anti-static ) acrylic sheet.

3. clean booth purification level selection:
More customers will choose one thousand clean booth , or ten thousand clean booth , a small number of customers will choose one hundred or ten thousand . In short, clean booth -level choices that customers need cleanliness may be, but relatively clean booth closed , such as when selecting clean booth level is relatively low , they tend to bring some side effects : insufficient cooling capacity , will shed staff in a clean I feel more hot, so the actual and the customer communication process , you need to pay attention to this point.

4. The cost of the clean and dust-free workshop shed comparison:
Generally speaking , most customers will clean booth built in the clean room , but some customers do not want to build a separate clean room, clean booth in the air conditioning system and does not consider air shower , pass the case of window cleaning equipment , etc. cost clean booth is about 40% to 60% clean room cost , depending on the customer 's choice of clean booth material , as well as the size of the clean booth . The greater the need to clean the area , the cost of clean and dust-free workshop shed will be smaller compared to the difference.

5. clean booth advantages:
A. Construction of fast, easy installation
B. low cost , easy maintenance
C. easy to control , FFU each comes with fan;

6. clean booth drawbacks:
A. because of the extensive use of FFU fan filter unit , so clean booth noise may be relatively large ;
B. FFU comes with fan , fan and more, to maintain high frequencies ;
C. due to reasons of space air , clean shed will often feel hot ;

Biological Safety Cabinet Specifications of Anlaitech Brand is On sales! Now!!

Biological Safety Cabinet Specifications of Anlaitech Brand

On sales!! Cost only 4876USD PER UNIT EX FACTORY

Model:  BSC-1500II-B2-X

Working area: 1300*600*660mm(W*D*H)

External size: 1500*850*2200mm(W*D*H)

Material: epoxy powder coated cold rolled steel for body

work zone made of 304 stainless steel

Safety height:</=200mm

Max opening: 400mm

Inflow velocity: 0.53m/s

Down flow velocity: 0.33m/s

Filter: 2set HEPA filter (99.999%@0.3um)

Noise:</=65dB

Front window: two layer toughened glasses (T=5mm)

UV lamp: 30W*1

Fluorescent lamp: 28W*1

Lighting(Lux)>/=800

Water and Gas tap: 1pc of each

Waterproof socket: 2pc

VFD display, microprocessor control system

Airflow:100% air exhaust

Cast wheel: directional wheels

Power: 1500W, 220V 50hz, 1phase

Welcome to us for details...
Order more save more!!
Sales Consultant, Vanessa ( email: wangvanlu@gmail.com)
Web: www.cleanroomffu.com

Matched Medical Standard ISO

We also not expect such a short period of time to complete 6sets Air Shower Clean room

We also not expect such a short period of time to complete 11sets Air Shower Clean room
Customer of AIMTR Electronics(EMS industry) orders 11sets Air Shower room from us, delivery time beat our limited , fixed term must be used these air shower for their EMS industry clean room area, and only 24 hours downtime per month, but give a slightly shock to our manage Mr Liu who charged clean room equipment producing section, but order is signed, we shall try our best to do so.

Leave our sourcing and production times are only seven days time, and the quality is also very demanding, how to do it ? Procurement, is expected to open, spraying, grinding, assembly , quality control, packaging, logistics after a brief meeting, the rapid division of labor, work instantly .

Unexpected things tend to happen miraculously, orders 25^th of Sept. smooth delivery than expected for almost a full day ahead of time to the customer. Afterwards, we Section Chief Liu and his colleagues are still surprised: " We did not expect such a short period of time to complete all set air shower rooms ," perhaps anxious customer anxious mentality appeal to every one of my colleagues , and it can not play out of our own imagine the energy to.

Prepared by:Corporate Communications Department of Anlaitech

Clean Room Automation Concept

Currently, injection drug Association (PDA) as the representative to agencies are actively promoting clean room and laboratory automation environments, thus completely eliminating the need for manual operation, the experiment paperless monitoring. In the clean room, a clear recommendation on the sampling point as quickly as possible to complete the automation of the collection . The following is a PDA- EM manual recommends :

"…by clean room touch pad and computer is automatically sent the terminal data to the clean room ."

" The program involves the need for manual data collection , data must be collected through a portable product to download data directly to a computer system in order to achieve the direct transmission of data , there is no risk of contamination ."

In the laboratory , the report also advocates automation , the following is recommended that EM manual :

"Analysis environmental data and Development Trend is the core to descript the process stability and evaluation of the overall control performance ."

EM report must be "…accurate , traceable , timely and have a good file backup file .”

Scanning below, follow us for the latest industry trends about clean room

Skype: wangvanlu

Tel: 0086-13826021570

We are dedicated on clean room Ffu(fan filter HEPA unit), because we have a brave heart!

We are dedicated on clean room Ffus(fan filter HEPA unit), because we have a brave heart!

We dedicated our firm. On FFU products, we have been focused on product appearance, structure and constantly adjust continuously optimized. We have developed for the different needs of customers of different types of products, ultra-thin, DC, 1175X1175mm large size , large amount of wind and so on.

The appearance of our FFUs is easy to use degrees , we also continued to improve : Improved multi-angle rotary knob, the vortex outlet, convex Laminating nameplate ...... faster to promote the upgrading of products, only for a better experience for our customers . All perseverance because we have a brave heart.

The same power of fans, wind speed, airflow, heat, durability , the failure rate to teach the same brand, the advantages are obvious. More than 2000 customers, 10 years of quality proof " 0 fault" "0 Maintenance " Brave heart also from the strength, the strength of the cast of "Anlaitech" brand Clean room FFUs.