The hottest pharmaceutical industry ensures the su

2022-08-16
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Pharmaceutical industry: to ensure the success of sealing (Part 2)

the main parameters to be analyzed include:

1 Batch processing requirements

a. unit operation

b. temperature and humidity requirements

c. product weight range and volume

d. product yield

2 Production process and product transfer between unit operations (such as weight, mixing, product addition, mixing, oscillation, mixing)

3 Safety requirements

a. product explosion

b. environmental elements (connection, weight, lateral movement in the isolation system)

4 Quality requirements

a. verification

b. NDA requirements

c. according to FDA requirements for supac-ir/mr production equipment, the equipment should be replaceable

5 Equipment limitation

a. maintenance

b. human machine interface (HMI)

c. other manual control

d. equipment settings and components

6 Isolation limits

a. how do products enter and exit the isolation system

b. how is waste discharged from the isolation system

c. the testing principle of equipment components and constant speed stretching method refers to: how does the tensile strength tester enter and exit the isolation system under the condition of constant speed stretching

d. once the integrity of the system is destroyed, how should the isolation system respond

e. how to clean the isolation system

in consideration of efficiency, it is not necessary for all team members to intervene in the project at the same time. The workshop team can be responsible for items, and the supplier can be responsible for items 5 and 6

q5: which isolation technology suppliers have you mainly cooperated with? Are they considering locating in Puerto Rico? Or is there a multinational enterprise that wants to do business in Puerto Rico

mc/jr: Puerto Rico's isolation system manufacturers mainly include Carlisle, powder Systems Limited (PSL), closed Application Engineering (ACE), La calhene and isolation solutions. Most of these suppliers have representative offices in Puerto Rico or often come to Puerto Rico to provide support

q6: many devices are designed without considering sealing. Is this a challenge? What kind of equipment have you seen that can work very well with an isolation system

mc/jr: yes! Many manufacturers of oral solid preparation production equipment have begun to take sealing into account in their systems, while manufacturers of product weighing, mixing, solvent configuration, crushing, fluidized drying, rolling and compressor equipment are now integrating sealing performance into their product design. Some manufacturers achieve this by adding CIP and WIP to the system, while others achieve this by applying isolation technology

q7: do you know that there are new ways to make raw materials enter and leave in the large isolation system? Where is the bottleneck

mc/jr: the isolation system mainly adopts five access methods:

1 Air lock

2 Rapid exchange import and export (rtps)

3 Closing valve

4 Inflatable seal

5 Bagging in and out

what is truly original is a pre made packaging bag of different sizes that can be adhered to the sealing valve. These sealing valves themselves are usually made of plastic or materials that are lighter and easier to handle than stainless steel

q8: how to control the access of operators? How about the latest technology in this area

mc/jr: a well-designed isolation system can facilitate the access of operators by maintaining equipment parts outside the system. Modifying and selecting the correct process equipment and access methods can make the transformation and maintenance of equipment easier. For example, for a product close to 10 to 15 kg, it can be considered to use mooring station instead of manual RTP connection, or it can be considered to use lifting technology to stop RTP

q9: what are the challenges to put electrical equipment into the isolation system? Especially toxic and harmful substances? Can you give an example of how you overcome this danger

mc/jr: if the product is toxic and harmful, the electrical equipment in the isolation system will become a hidden danger for the method of zero adjustment of the testing machine. Dust must be minimized. You can evaluate the safety through the following methods:

1 Set dust collection points at important positions

2. The isolation system must be properly grounded

3. Use explosion-proof equipment

4. Move flammable substances such as motors and controllers outside the isolation system

5. Stop the isolation system

q10: will the climate of the island country with high temperature and humidity have a special impact on the project and the application of the isolation system? If so, how can you overcome this challenge

mc/jr: generally, we will use the central air conditioning system with relatively low installation, operation and verification costs to control high temperature and humidity, but we also see a trend to control the temperature and humidity in the isolation system to replace the central air conditioning system, especially for the pilot production system

q11: nitrogen is often used to cool closed spaces and reduce the humidity of the air. What measures do you have for this

mc/jr: you have to humidify the isolation system. In one case, we work with our supplier PSL to add deionized water or purified water to the nitrogen stream to increase the humidity. Humidity detectors are used in the isolation system for monitoring and control

q12: in Puerto Rico, the establishment of relations seems to be an important factor in the success of the project. What's your explanation

mc/jr: this is an important aspect that everyone working in Puerto Rico needs to understand if you consider the sensitivity of medical and biological projects. Its sensitivity lies in: a) it is very important to shorten the time to market with the characteristics of wide measurement range, high accuracy and fast response; b) it cannot be at the expense of quality; c) the project is carried out by a team composed of multiple departments, so it is very important to establish a tough and balanced relationship. In addition, from the first day, it is very important to fully understand the purpose of the project and the roles and needs of each important member, and know how to involve these members in the project at the right time

in Puerto Rico, once people feel that their needs are fully expressed, they will feel very satisfied. It can be said that the importance of information communication is always above actual implementation. (end)

source: Shenzhen packaging

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