IJM SingleCore NanoProducer

SYSTEMS FOR LIPID NANOPARTICLE (LNP) PRODUCTION AND FORMULATION

The number of parallel units depends on the application. Also, the number of pumps, flow meters, jets mixers and pipes can be adapted to the required conditions and scale. All IJM NanoProducers are built in a stainless steel frame on casters and are suitable for CIP cleaning procedures in pharmaceutical production. The IJM DoubleCore NanoProducer contains two parallel mixing units. Each unit consists of four pumps. Concentrated Active Pharmaceutical Ingredient (API) solution is diluted first and then mixed with the organic phase. Finally, the mixture is quenched in a third mixer. Both units can be operated independently. The IJM NanoProducer can be configured with up to eight parallel mixing units depending on the customer requirements. Each unit consists of two pumps to deliver lipid and API streams, two flow meters for flow control and one jet mixer. Depending on the configuration, the predilution of the API and quenching can be performed for the combined flow of all units in one process step outside the Impingement Jets Mixing (IJM) NanoProducer. 

IJM SingleCore NanoProducer脂質(zhì)納米顆粒(lnp)生產(chǎn)和配方系統(tǒng)

并聯(lián)單元的數(shù)量取決于應(yīng)用程序。此外，泵、流量計(jì)、射流混合器和管道的數(shù)量可以適應(yīng)所需的條件和規(guī)模。所有IJM NanoProducer建立在一個(gè)不銹鋼框架上的腳輪，適合在制藥生產(chǎn)的CIP清洗程序。IJM DoubleCore NanoProducer包含兩個(gè)并行混合單元。每個(gè)機(jī)組由四個(gè)泵組成。濃縮活性藥物成分(API)溶液首先稀釋?zhuān)缓笈c有機(jī)相混合。最后，混合物在第三個(gè)混合器中被淬火。兩個(gè)裝置都可以獨(dú)立運(yùn)行。根據(jù)客戶(hù)的要求，IJM NanoProducer可以配置多達(dá)8個(gè)并行混合單元。每個(gè)單元包括兩個(gè)泵輸送脂質(zhì)和API流，兩個(gè)流量計(jì)用于流量控制和一個(gè)噴射混合器。根據(jù)配置，API的預(yù)稀釋和淬火（quenching）可以在撞擊射流混合(IJM)NanoProducer以外的一個(gè)工藝步驟中對(duì)所有單元的組合流進(jìn)行。

THE TECHNOLOGY

Impingement Jets Mixing Technology (IJM) enables the formulation and production of high-quality lipid nanoparticles carrying API (e.g. for mRNA vaccines). The encapsulation process of active pharmaceutical ingredients with lipids is based on Impingement Jets Mixing Technology, where two streams collide at high velocity in a jet mixing chamber. One of the streams contains the lipids in organic solvents and the other stream the API in water.

技術(shù)

撞擊射流混合技術(shù)(IJM)可以配制和生產(chǎn)攜帶API的高質(zhì)量脂質(zhì)納米顆粒(例如用于mRNA疫苗)?；钚运幬锍煞峙c脂類(lèi)的封裝過(guò)程是基于撞擊射流混合技術(shù)，即兩股流在射流混合室中高速碰撞。其中一條流包含有機(jī)溶劑中的脂類(lèi)，另一條流包含水中的API。

The mixing at high velocity reduces the solubility of the lipids so that homogenous nanoparticles are formed. The quality of nanoparticles depends on the streams‘ flow stability, the mixer geometry and the fluid velocities. As a final step, the mixture is quenched to stop particle growth.

高速的混合降低了脂質(zhì)的溶解度，從而形成了均勻的納米顆粒。納米粒子的質(zhì)量取決于流體的流動(dòng)穩(wěn)定性、混合器的幾何形狀和流體速度。作為步，混合物被淬火（quenched）以阻止粒子生長(zhǎng)。

System for LNP formulation consisting of:

KNAUER high-pressure dosing pumps 80P

Coriolis flow meters

KNAUER IJM mixers

Inlet manifolds for lipid/ethanol mixture and API/buffer mixture

Outlet manifold for LNP solution

Back-seal washing system

Frame (stainless steel system 1.4301)

Installation & familiarization by KNAUER

A customized technical documentation which is order- and article-related

Customer Service before, during and after the set up

Capillary customization and labeling

FAT (Factory Acceptance Test at KNAUER Berlin)

SAT (Site Acceptance Test at customer site)

LNP配方系統(tǒng)包括:

KNAUER高壓給料泵80P

Coriolis 流量計(jì)

KNAUER IJM混合器

用于脂質(zhì)/乙醇混合物和API/緩沖混合物的入口歧管

LNP溶液的出口歧管

Back-seal清洗系統(tǒng)

框架(不銹鋼系統(tǒng)1.4301)

KNAUER的安裝和熟悉

與訂單和產(chǎn)品相關(guān)的定制技術(shù)文檔

安裝前、安裝中、安裝后的客戶(hù)服務(wù)

毛細(xì)管定制和標(biāo)簽

FAT (KNAUER Berlin工廠驗(yàn)收測(cè)試)

SAT(客戶(hù)現(xiàn)場(chǎng)驗(yàn)收測(cè)試)

IJM SingleCore NanoProducer

Number of impingement jets mixers: 1

Number of pumps:4

Number of flow meters:4

Number of valves:1

Process connection inlet**:1/2" Tri-clamp (4 inlets)

Process connection outlet**:1/2" Tri-clamp (1 outlet)

Volumetric flow rate:up to 1 l/min

Volumetric flow rate:up to 60 l/h

Maximum operating pressure***:95bar (1378 psi)

Liquid temperature range:4–60 °C (39.2–140 °F)

Wetted materials:stainless steel, PEEK, titanium, FFKM, PTFE (GFP 55), aluminum oxide, ruby, sapphire, EPDM, zirconium oxide, POM, hastelloy

Software:CDS, 21 CFR part 11 and GAMP 5 compliant

Interfaces:pump: LAN, RS-232, pin header connectors; flow meter: RS-232 + FLOW-BUS™; valve drive: LAN

Power supply:pump: 100–240 VAC single phase, 50/60 Hz; flow meter: 115/230 VAC single phase, 

50/60 Hz 24V DC Power supply; valve drive: 115/230 VAC single phase, 50/60 Hz 24V DC Power supply; PC: 100–240 VAC single phase, 50/60 Hz; monitor: 100–240 VAC single phase, 50/60 Hz; network switch: 100–240 VAC single phase, 50/60 Hz, 12 V DC Power supply

Power consumption (per device):pump: maximum 320 W; flow meter: 3 W; valve drive: 65 W; PC: 1000 W; monitor: 380 W; network switch: 50 W

Ambient conditions:temperature range: 4–40 °C; 39.2?104 °F; below 90 % humidity (non-condensing)

Dimensions (W x H x D):900x 915 x 700 mm

Net weight (approx.):150 kg

API-predilution and quenching:Yes

Customized technical documentation, order-ａnd article-related:Yes

Factory acceptance test:Yes

Site acceptance test:Yes

撞擊射流混合器數(shù)量:1

泵的數(shù)量:4

流量計(jì)數(shù)量:4個(gè)

閥門(mén)數(shù)量:1

工藝連接入口**:1/2"Tri-clamp(4個(gè)入口)

工藝連接插座**:1/2”Tri-clamp(1個(gè)出口)

容積流速:可達(dá)1升/分鐘

容積流速:高達(dá)60升/小時(shí)

工作壓力***:95bar (1378 psi)

液體溫度范圍:4-60°C(39.2-140°F)

濕性材料:不銹鋼，PEEK，鈦，F(xiàn)FKM, PTFE (GFP 55)，氧化鋁，紅寶石，藍(lán)寶石，EPDM，氧化鋯，POM，哈氏合金

軟件:CDS, 21 CFR part 11和gamp5兼容

接口:泵:LAN, RS-232，引腳頭連接器;流量計(jì):RS-232 + flow - bus™;閥門(mén)驅(qū)動(dòng):局域網(wǎng)

電源:泵:100-240伏單相，50/60赫茲;流量計(jì):115/230伏單相，50/ 60hz 24V DC電源;閥門(mén)驅(qū)動(dòng):115/230 VAC單相，50/60 Hz 24V直流電源;PC: 100-240伏單相，50/60赫茲;顯示器:100-240伏單相，50/60赫茲;網(wǎng)絡(luò)開(kāi)關(guān):100-240伏單相，50/ 60hz, 12v DC電源

功耗(每臺(tái)設(shè)備):泵:320w;流量計(jì):3w;閥傳動(dòng):65w;電腦:1000 W;監(jiān)控:380 W;網(wǎng)絡(luò)交換機(jī):50w

環(huán)境條件:溫度范圍:4-40°C;39.2?104°F;濕度低于90%(不凝結(jié))

尺寸(寬×高×深):900 × 915 × 700毫米

凈重(約):150公斤

API-預(yù)稀釋和淬火（quenching）:是的

與訂單和產(chǎn)品相關(guān)的定制技術(shù)文檔:是

工廠驗(yàn)收測(cè)試:是的

現(xiàn)場(chǎng)驗(yàn)收測(cè)試:是的